protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05498701 | 10.1.9 | Publication Policy | 10.1.9. Publication Policy For multicenter trials, the primary publication will be a joint publication developed by the investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. The investigator agrees to refer to the primary publication in any subsequent publications. Pfizer will... | [] |
NCT05498701 | 10.1.10 | Sponsor's Medically Qualified Individual | 10.1.10. Sponsor's Medically Qualified Individual The contact information for the sponsor's MQI for the study is documented in the study contact list located in the CTMS. To facilitate access to their investigator and the sponsor's MQI for study-related medical questions or problems from nonstudy healthcare professiona... | [] |
NCT05498701 | 10.3 | Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting | 10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting | [] |
NCT05498701 | 10.3.1 | Definition of AE | 10.3.1. Definition of AE
AE Definition - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. - Note: An AE can therefore be any unfavorable and unintended sign (includ... | [
"AE Definition",
"Events Meeting the AE Definition",
"Events NOT Meeting the AE Definition"
] |
NCT05498701 | 10.3.2 | Definition of an SAE | 10.3.2. Definition of an SAE An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed below:
a. Results in death
b. Is life-threatening The term "life-threatening" in the definition of "serious" refers to an event in which the participant was at risk of death at... | [
"a. Results in death",
"b. Is life-threatening",
"c. Requires inpatient hospitalization or prolongation of existing hospitalization",
"d. Results in persistent or significant disability/incapacity",
"e. Is a congenital anomaly/birth defect",
"f. Is a suspected transmission via a Pfizer product of an infec... |
NCT05498701 | 10.3.3 | Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active Collection Period | 10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active Collection Period
AE and SAE Recording/Reporting The table below summarizes the requirements for recording AEs on the CRF and for reporting SAEs on the CT SAE Report Form to Pfizer Safety throughout the active collection period. These requi... | [
"AE and SAE Recording/Reporting",
"Assessment of Intensity",
"Assessment of Causality",
"Follow-Up of AEs and SAEs"
] |
NCT05498701 | 10.3.4 | Reporting of SAEs | 10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via the CT SAE Report Form - Facsimile transmission of the CT SAE Report Form is the preferred method to transmit this information to Pfizer Safety. - In circumstances when the facsimile is not working, an alternative method should be used, eg, secured (Transpor... | [
"SAE Reporting to Pfizer Safety via the CT SAE Report Form"
] |
NCT05498701 | 10.4 | Appendix 4: Contraceptive and Barrier Guidance | 10.4. Appendix 4: Contraceptive and Barrier Guidance | [] |
NCT05498701 | 10.4.1 | Male Participant Reproductive Inclusion Criteria | 10.4.1. Male Participant Reproductive Inclusion Criteria No contraception methods are required for male participants in this study, as the calculated safety margin is ≥100-fold between the estimated maternal exposure due to seminal transfer and the NOAEL for serious manifestations of developmental toxicity in nonclinic... | [] |
NCT05498701 | 10.4.2 | Female Participant Reproductive Inclusion Criteria | 10.4.2. Female Participant Reproductive Inclusion Criteria The criterion below is part of Inclusion Criterion 1 (Age and Sex; [Section 5.1\)](#page-24-0) and specify the reproductive requirements for including female participants. A female participant is eligible to participate if she is not pregnant or breastfeeding a... | [
"• Is not a WOCBP"
] |
NCT05498701 | 10.6 | Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments Potential Cases of Drug-Induced Liver Injury | 10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments Potential Cases of Drug-Induced Liver Injury Humans exposed to a drug who show no sign of liver injury (as determined by elevations in transaminases) are termed "tolerators," while those who show transient liver injury but adapt are termed "ada... | [] |
NCT05498701 | 10.7 | Appendix 7: Kidney Safety: Monitoring Guidelines | 10.7. Appendix 7: Kidney Safety: Monitoring Guidelines | [] |
NCT05498701 | 10.7.1 | Laboratory Assessment of Change in Kidney Function and Detection of Kidney Injury | 10.7.1. Laboratory Assessment of Change in Kidney Function and Detection of Kidney Injury Standard kidney safety monitoring requires assessment of baseline and postbaseline serum creatinine Scr-based eGFR or eCrCl). Baseline and postbaseline serum Scys makes it feasible to distinguish AKI from other causes of Scr incre... | [] |
NCT05498701 | 10.7.2 | Age-Specific Kidney Function Calculation Recommendations | 10.7.2. Age-Specific Kidney Function Calculation Recommendations | [] |
NCT05498701 | 10.7.2.1 | Adults (18 Years and Above)—2021 CKD-EPI Equations | 10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI Equations | 2021 CKDEPIScr Only | Scr(mg/dL) | Scys(mg/L) | Recommended eGFR Equation | |-----------------------------------------|----------------|----------------|---------------------------------------------------------------------| | Female | if ≤0.7 | N/A | eGFR =... | [] |
NCT05498701 | 10.7.3 | Adverse Event Grading for Kidney Safety Laboratory Abnormalities | 10.7.3. Adverse Event Grading for Kidney Safety Laboratory Abnormalities AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to KDIGO criteria. | [] |
NCT05498701 | 10.8 | Appendix 8: ECG Findings of Potential Clinical Concern | 10.8. Appendix 8: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs - Marked sinus bradycardia (rate 280 ms. - New prolongation of QTcF to >480 ms (absolute) or by ≥60 ms from baseline. - New-onset atrial flutter or fibrillation, with controlled ventricular response rate: ie, rate 30 seco... | [
"ECG Findings That May Qualify as AEs",
"ECG Findings That May Qualify as SAEs",
"ECG Findings That Qualify as SAEs"
] |
NCT05498701 | 10.9 | Appendix 9: Prohibited Concomitant Medications That May Result in DDI Not applicable to this study. | 10.9. Appendix 9: Prohibited Concomitant Medications That May Result in DDI Not applicable to this study. | [] |
NCT05498701 | 10.10 | Appendix 10: Abbreviations | 10.10. Appendix 10: Abbreviations The following is a list of abbreviations that may be used in the protocol. | Abbreviation | Term | | | | |----------------|----------------------------------------------------------------------------------------------|--|--|--| | A1toA3 | albuminuria(KDIGOalbuminuriaseveritystandardiza... | [] |
NCT05498701 | 11 | REFERENCES | 11. REFERENCES i Investigator's Brochure, B346 (PF-06291826) 19 Mar 2021 | [] |
NCT05529472 | 1 | WORKING VERSION HISTORY | 1. WORKING VERSION HISTORY     | [] |
NCT05529472 | 2 | STUDY SUMMARY | 2. STUDY SUMMARY | | [L | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05529472 | 3 | ABBREVIATIONS | 3. ABBREVIATIONS | 3. | ABBREVIATIONS | | |----------|-------------------------------------|--| | | | | | ADE | Adverse Device Effect | | | AE | Adverse Event | | | ATK | Above the Knee | | | BTK | Below the Knee | | | BA | Balloon Angioplasty | | | CAPA | Corrective Action Preventive Action | | | CEC | Clinical Events... | [] |
NCT05529472 | 4 | DEFINITIONS | 4. DEFINITIONS | Term | Definition | |--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"INTRODUCTION",
"DEVICE DESCRIPTION",
"Device Name and Indications for Use",
"Device History and Description"
] |
NCT05529472 | 6.3 | Principles of Operation | 6.3 Principles of Operation The OAS is designed to reduce occlusive material and improve lumen patency by using a rotating, diamond-coated crown. The combination of the off-set crown mass and rapid rotation of the crown creates centrifugal forces that press the diamond-coated crown against the stenotic lesion. With eac... | [] |
NCT05529472 | 6.4 | Devices Used in the Study | 6.4 Devices Used in the Study The device under investigation in this study is the CSI Peripheral OAS. Approximately one device per subject will be used. - imaging catheter (e.g., Phillips Eagle Eye® Platinum IVUS Catheter) e POBA: Per physician's standard of care, any approved POBA is allowed - e DCB: Medtronic IN.PACT... | [] |
NCT05529472 | 6.5 | Manufacturer | 6.5 Manufacturer | In addition, the following commercially available products will also be used in the study: | | | | | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--| | Intra... | [
"Device Handling and Traceability",
"Device Storage",
"Device Accountability",
"Device Return",
"OBJECTIVE",
"STUDY ENDPOINTS",
"Primary Endpoint",
"Secondary Endpoints",
"STUDY DESIGN",
"Description of Study Design",
"Study Duration",
"Enrollment Criteria",
"Justification of Performance Goa... |
NCT05529472 | 9.1.4 | Study Hypothesis | 9.1.4 Study Hypothesis The safety and efficacy of the OAS device will be evaluated by the rate of Acute Device Success (Section 8.1) against a pre-defined success criteria of 50% (Section 9.1.3). Comparisons will be made based on the following hypothesis test: > Ho: ns50% Where: = s = the probability of Acute Device Su... | [] |
NCT05529472 | 9.1.5 | Justification of the Sample Size | 9.1.5 Justification of the Sample Size A sample of 62 subjects meeting Independent Physician Review is required to reject the null hypothesis (Table 5). The sample size was determined based on the following: Performance Goal (one-sided) Size - e Approximately 90% power - \ Aone-sided o-level of 0.025 Table 5: Sample Si... | [] |
NCT05529472 | 10 | DATA COLLECTION | 10.DATA COLLECTION | [] |
NCT05529472 | 10.1 | Study Data Collection | 10.1 Study Data Collection The electronic case report forms (eCRF) for this study will be maintained in an electronic data capture (EDC) system. Site personnel who are trained and delegated the task will enter data from the subject''s source documents stored in the subject's medical record into the eCRF accessed remote... | [
"Notes:",
"STUDY ENROLLMENT",
"Baseline",
"Study Medications",
"Verify General Inclusion and Exclusion Criteria",
"General Inclusion Criteria",
"General Exclusion Criteria",
"Informed Consent",
"Verify Clinical Trial Treatment Inclusion and Exclusion Criteria",
"Clinical Trial Treatment Inclusion ... |
NCT05529472 | 12.3 | Role of CSI Representatives During the Procedure | 12.3 Role of CSI Representatives During the Procedure Personnel representing CSI may attend the procedure to provide technical support relative to the use of the OAD. All of these actions will be done under the careful direction of the Principal Investigator. | [] |
NCT05529472 | 12.4 | Non-Target Limb Treatment | 12.4 Non-Target Limb Treatment If subject presents with bilateral disease with one eligible lesion in both legs, the target limb will be determined by physician's discretion. Non-target limbs requiring PTA treatment must be treated either >30 days prior to clinical trial treatment or > 30 days after clinical trial trea... | [] |
NCT05529472 | 13 | DISCHARGE | 13.DISCHARGE Refer to Table 7 for Discharge data collection requirements. | [] |
NCT05529472 | 13.1 | Discharge Medications | 13.1 Discharge Medications Subjects are recommended to follow an antiplatelet therapy protocol at the discretion of the investigator
FOLLOW-UP The following sections describe follow-up requirements for all enrolled subjects in the KAIZEN study. All follow-up assessments and visits must be performed by someone who is s... | [
"FOLLOW-UP",
"30-Day In-hospital Follow-up Visit or Telephone Follow-up Assessment",
"6-Month Follow-up Visit",
"OVERVIEW OF IMAGING DATA FLOW",
"ADVERSE EVENTS",
"Adverse Event Requirements",
"Adverse Event Definitions",
"Adverse Event Relatedness",
"Reporting Adverse Events and Follow-Up",
"Devi... |
NCT05529472 | 25 | STATISTICAL METHODS | 25.STATISTICAL METHODS An overview of statistical methods and analyses are included below. Detailed analyses are outlined in a separate Statistical Analysis Plan (SAP). | [] |
NCT05529472 | 25.1 | Data Analysis | 25.1 Data Analysis The Primary Analysis will be based on the Modified Intent to Treat (mITT) analysis set, unless otherwise noted. Enrolled subjects are those who met all of the Inclusion and none of the Exclusion criteria, signed an Institutional Review Board (IRB) approved Informed Consent Form (ICF), and had the Per... | [
"Roll-in Analysis Set",
"Timing of Analysis",
"Identifying Target Lesions",
"Endpoint Analyses",
"Primary Endpoint Analysis",
"Primary Endpoint Sensitivity Analysis",
"Secondary Endpoint Analysis",
"Roll-in Analysis",
"RISK ANALYSIS",
"Risks Associated with OAS",
"Risk Associated with DCB",
"R... |
NCT05535920 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT05535920 | 1.1 | Background and Rationale for Conducting the Study | 1.1 Background and Rationale for Conducting the Study Patients with end-stage renal disease (ESRD) have significantly higher mortality rates compared to non-dialysis populations. Recent data from the United States Renal Data System (USRDS) database finds that the annualized death rates for all ESRD patients is approxim... | [] |
NCT05535920 | 1.1.1 | Background and Significance | 1.1.1 Background and Significance Atrial fibrillation is the most common cardiac arrhythmia affecting about 2% of those aged 2.0 K+) dialysate. However, sudden death rates continued to climb up approximately 57% when the low K+ dialysate was consistently used. In contrast, sudden death rates were the lowest among those... | [] |
NCT05535920 | 1.2 | Rationale for Study Design, Doses, and Control Groups | 1.2 Rationale for Study Design, Doses, and Control Groups Chronic outpatient hemodialysis patients have high rates of rapid changes in potassium and other electrolytes critical to the generation cardiac arrythmias. A growing body of data suggests that intra-dialytic K+ levels fall to level of 2.0 or lower and are a pot... | [] |
NCT05535920 | 1.3 | Benefit/risk and ethical assessment | 1.3 Benefit/risk and ethical assessment End stage renal disease (ESRD) patients have significantly higher mortality rates compared to non-dialysis populations. Recent data from the USRDS database finds that the annualize death rates for all ESRD patients is approximately 23.7% with cardiac disease accounting for 40% of... | [] |
NCT05535920 | 1.4 | Study Design | 1.4 Study Design This is a prospective, open-labelled, randomized, 2x2 cross-over design study of 88 patients with end stage renal disease (ESRD) receiving routine out-patient dialysis using a standard 2.0 potassium ion (K+)/2.5 calcium ion (Ca++) dialysate bath. The overall aim of the study is to determine whether con... | [] |
NCT05535920 | 2 | STUDY OBJECTIVES | 2. STUDY OBJECTIVES | [] |
NCT05535920 | 2.1 | Primary Objective | 2.1 Primary Objective | Primary Objective:Atrial Fibrillation Rates | Primary Outcome Measure: | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05535920 | 2.2 | Secondary Objectives | 2.2 Secondary Objectives | Secondary Efficacy Objective#1:ClinicallySignificant Cardiac Arrhythmia Rates | Secondary Outcome Measure: | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05535920 | 2.3 | Safety Objectives | 2.3 Safety Objectives | Safety Objective#1:Lokelma-InducedHypokalemia | Safety Outcome Measure: | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05535920 | 2.4 | Exploratory Objectives | 2.4 Exploratory Objectives | Exploratory Objectives: | Outcome Measures: | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05535920 | 3 | SUBJECT SELECTION, ENROLLMENT, RANDOMIZATION, RESTRICTIONS, DISCONTINUATION AND WITHDRAWAL | 3. SUBJECT SELECTION, ENROLLMENT, RANDOMIZATION, RESTRICTIONS, DISCONTINUATION AND WITHDRAWAL All study participants will be recruited from specialist (nephrology) care clinics. Each subject must meet all of the inclusion criteria and none of the exclusion criteria for this study. Under no circumstances can there be ex... | [] |
NCT05535920 | 3.1 | Inclusion Criteria | 3.1 Inclusion Criteria For inclusion in the study subjects should fulfil the following criteria based on local regulations: - 1. Provision of informed consent prior to any study-specific procedures - 2. Female or male aged above 18 years - 3. Patients with ESRD receiving hemodialysis three times per week for a minimum ... | [] |
NCT05535920 | 3.2 | Exclusion Criteria | 3.2 Exclusion Criteria Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Exclusion Criteria Related to the Underlying Condition: - 1. Patients with a QTc(f) > 550 msec and/or Congenital long QT syndrome - 2. Patients with a Haemoglobin 6.5 mEq/L measured by Piccolo POCT afte... | [
"Exclusion Criteria Related to the Underlying Condition:",
"Exclusion Criteria Related to Other Medical Conditions and Treatments:",
"Exclusion Criteria Related to the Investigational Product (IP):",
"Other/General Exclusion Criteria:"
] |
NCT05535920 | 3.3 | Subject Enrollment and Randomization | 3.3 Subject Enrollment and Randomization Study participants will be recruited from each site's current and actively managed dialysis population. ESRD patients on a three times weekly hemodialysis regimen will be identified through regular monthly rounding visits by the site PI / Delegated Staff and through interactions... | [] |
NCT05535920 | 3.4 | Procedures for Handling Incorrectly Enrolled or Randomized Subjects | 3.4 Procedures for Handling Incorrectly Enrolled or Randomized Subjects Patients who fail to meet the eligibility criteria should not, under any circumstances, be enrolled or receive study medication. There can be no exceptions to this rule. Patients who are enrolled, but subsequently found not to meet all the eligibil... | [] |
NCT05535920 | 3.5 | Methods for Assigning Treatment Groups | 3.5 Methods for Assigning Treatment Groups The study sponsor (NephroNet) will be responsible for preparing the randomization scheme. Permuted block randomization using 2x2 Latin Squares will be applied to ensure a balanced assignment (1:1 ratio) to the two treatment sequences in the study. Patients who meet all inclusi... | [] |
NCT05535920 | 3.6 | Methods for ensuring blinding | 3.6 Methods for ensuring blinding Not applicable; this is an open label study. | [] |
NCT05535920 | 3.7 | Methods for unblinding | 3.7 Methods for unblinding Not applicable; this is an open label study. | [] |
NCT05535920 | 3.8 | Restrictions | 3.8 Restrictions Apart from the limitations described in the exclusion criteria (see Section 3.2), there will be no restrictions affecting patients' daily life activities associated with participation in the study. | [] |
NCT05535920 | 3.9 | Discontinuation of Investigational Product | 3.9 Discontinuation of Investigational Product Patients may be discontinued from investigational product (IP) in the following situations: - Patient decision. The participant is at any time free to discontinue treatment, without prejudice to further treatment; - Incorrectly randomized participant where violation of the... | [] |
NCT05535920 | 3.9.1 | Procedures for Discontinuation of a Patient from Investigational Product | 3.9.1 Procedures for Discontinuation of a Patient from Investigational Product At any time, patients are free to discontinue investigational product or withdraw from the study (i.e., investigational product and assessments – see Section 3.10), without prejudice to further treatment. Patients deciding to discontinue the... | [] |
NCT05535920 | 3.10 | Criteria for Withdrawal | 3.10 Criteria for Withdrawal Patients can decide to be discontinued from both investigational product and further study procedures/visits at any time (withdrawal of consent). | [] |
NCT05535920 | 3.10.1 | Screen failures | 3.10.1 Screen failures Screening failures are patients who do not fulfil the eligibility criteria for the study, and therefore must not be randomized. These patients should have the reason for study withdrawal recorded as 'Incorrect Enrollment' (i.e., patient does not meet the required inclusion/exclusion criteria). Th... | [] |
NCT05535920 | 3.10.2 | Withdrawal of the informed consent | 3.10.2 Withdrawal of the informed consent Patients are free to withdraw from the study at any time (investigational product and assessments), without prejudice to further treatment. A patient who withdraws consent will always be asked about the reason(s) and the presence of any AE. Regardless of the reason for withdraw... | [] |
NCT05535920 | 3.11 | Discontinuation of the study | 3.11 Discontinuation of the study The study may be stopped if, in the judgment of the Sponsor, trial participants are placed at undue risk because of clinically significant findings that: - meet individual stopping criteria or are otherwise considered significant - are assessed as causally related to study drug - are n... | [] |
NCT05535920 | 4 | STUDY PLAN AND TIMING OF PROCEDURES | 4. STUDY PLAN AND TIMING OF PROCEDURES The Study Plan and schedule of assessments is provided in Table 1. Details of study assessments completed during the Screening, Treatment, and Follow-up periods are included in sections 4.1, 4.2, and 4.3. Table 1 Study Plan and Schedule of Assessments | Study Period /Visit | Scree... | [] |
NCT05535920 | 4.1 | Screening Period | 4.1 Screening Period The process for identifying prospective study patients (pre-screening) is described in Section 3.3. Screening assessments will be carried out according to the schedule provided in Table 1. The following section details the screening activities, starting with the consent process. During screening, c... | [] |
NCT05535920 | 4.1.1 | Obtaining Written Informed Consent | 4.1.1 Obtaining Written Informed Consent Potential patients expressing a willingness to participate in the study will be interviewed by the Site PI or their qualified designee, and the study objectives, benefits and risks of participation, and study requirements will be thoroughly reviewed with the patient. The patient... | [] |
NCT05535920 | 4.1.2 | Assignment of Unique Patient Enrollment Number | 4.1.2 Assignment of Unique Patient Enrollment Number Consenting patients will be assigned a unique Patient Enrollment Number comprised by a 2 digit site number, and a sequentially assigned 3-digit number starting with 001. For example, at site 01, the first enrolled patient will be assigned 01-001, the second patient 0... | [] |
NCT05535920 | 4.1.3 | Recording of Demographic Data | 4.1.3 Recording of Demographic Data Demographic data (date of birth, sex, self-reported race, and ethnicity) will be recorded at screening. | [] |
NCT05535920 | 4.1.4 | Review of Medical/Surgical, Laboratory, and Medication History | 4.1.4 Review of Medical/Surgical, Laboratory, and Medication History Patient medical records and prior dialysis flow sheets will be reviewed to determine whether the patient meets all inclusion and none of the exclusion criteria. The review will include, but will not be limited to the following: 1) Routine "standard of... | [] |
NCT05535920 | 4.1.5 | Physical Exam | 4.1.5 Physical Exam A complete physical examination will be performed prior to the placement of the LINQ implantable recorder, with focus on general appearance, respiratory and cardiovascular systems, and lower extremities, and will include a limited neurological exam. | [] |
NCT05535920 | 4.1.6 | Vital Sign Measurements and Weight | 4.1.6 Vital Sign Measurements and Weight Measurement of vitals is standard of care throughout each dialysis session, and will include blood pressure, pulse, weight, and body temperature. Measurement of vitals and weight will be recorded post dialysis on Friday or Saturday prior to the long dialysis weekend and pre-dial... | [] |
NCT05535920 | 4.1.7 | 12-Lead Electrocardiogram (ECG) | 4.1.7 12-Lead Electrocardiogram (ECG) A standard 12-lead ECG recording will be performed and used for confirmation of eligibility. | [] |
NCT05535920 | 4.1.8 | K+ and PO4 Piccolo POCT System Measurements (Weeks -4 and -3) | 4.1.8 K+ and PO4 Piccolo POCT System Measurements (Weeks -4 and -3) Patients will have blood draws completed prior to dialysis on two (2) separate occasions following the long dialytic "weekends" (i.e., on two consecutive Mondays for patients on a Monday-Wednesday-Friday dialysis schedule or on two consecutive Tuesdays... | [
"Piccolo POCT System"
] |
NCT05535920 | 4.1.9 | Insertion of the Cardiac Loop Recorder (Week -2) | 4.1.9 Insertion of the Cardiac Loop Recorder (Week -2) Patients who have completed the screening assessments and are willing to proceed with study participation will be referred to a cardiac electrophysiologist (EP) or qualified implanter who is trained and experienced in the placement of the LINQ device. It is anticip... | [
"LINQ Device Insertion",
"Post-LINQ Device Insertion"
] |
NCT05535920 | 4.2 | Treatment period | 4.2 Treatment period Assessments during the treatment period will be carried out according to the schedule provided in Table 1. After completing the 2-week post-ILR insertion blanking period, patients will be switched to the dialysate arm that they had been allocated to through randomization. After a 2-week "accommodat... | [] |
NCT05535920 | 4.2.1 | Blood Draws (Weeks 3 to 10 and Weeks 13 to 20) | 4.2.1 Blood Draws (Weeks 3 to 10 and Weeks 13 to 20) During both 8-week treatment phases, the first twenty-five (25) patients randomized receiving standard treatment (hemodialysis using 2.0K+/2.5 Ca++ dialysate bath, without Lokelma supplementation) will undergo blood collection for select chemistry tests and determina... | [] |
NCT05535920 | 4.2.2 | Insertable Cardiac Loop Recordings (Weeks 3 to 10 and Weeks 13 to 20) | 4.2.2 Insertable Cardiac Loop Recordings (Weeks 3 to 10 and Weeks 13 to 20) ILR interrogation will be initiated at the end of each 2-week accommodation period (to the new dialysate) and will continue throughout the two 8-week treatment phases. Devices will not be interrogated during either 2-week accommodation periods ... | [
"Cardiac Data Monitoring"
] |
NCT05535920 | 4.2.3 | Cross-Over (Week 11) | 4.2.3 Cross-Over (Week 11) At the end of the first treatment phase (Weeks 3 to 10) of the study, all blood draws will be stopped for 2 weeks. Cardiac loop recording devices will not be interrogated during this 2-week accommodation period, and the data recorded during that time will not be used for analysis. Patients wh... | [] |
NCT05535920 | 4.3 | Follow-up period | 4.3 Follow-up period Assessments during the Follow-up period will be carried out according to the schedule provided in Table 1. After patients complete the 8-week Treatment Phase-2, all cardiac loop recording and nonstandard of care blood draws will stop. As part of the Follow-up, patients will be seen by the electroph... | [] |
NCT05535920 | 5 | STUDY ASSESSMENTS | 5. STUDY ASSESSMENTS The Investigators will ensure that data are recorded on the eCRFs as specified in the study protocol and in accordance with the instructions provided. The Investigators are responsible for the accuracy, completeness, and timeliness of the data recorded and of the answers to data queries according t... | [] |
NCT05535920 | 5.1 | Efficacy Assessments | 5.1 Efficacy Assessments | [] |
NCT05535920 | 5.1.1 | Atrial Fibrillation | 5.1.1 Atrial Fibrillation As described in Section 2.1, the primary objective of this study is to determine whether increasing the K+ concentration in a standard hemodialysis bath from 2.0 K+/2.5 Ca++ to a 3.0 K+/2.5 Ca++ composition with Lokelma will reduce the incidence of atrial fibrillation events. Atrial fibrillati... | [] |
NCT05535920 | 5.1.2 | Clinically Significant Cardiac Arrhythmias | 5.1.2 Clinically Significant Cardiac Arrhythmias As detailed in Section 2.2, the frequency and duration of post-dialysis CSCAs (defined as bradycardia, ventricular tachycardia and/or asystole) observed during experimental treatment compared to standard treatment will be evaluated as part of the secondary endpoints of t... | [] |
NCT05535920 | 5.1.3 | Potassium Measurements | 5.1.3 Potassium Measurements A further secondary objective of the study (see Section 2.2) is to determine whether the addition of oral sodium zirconium cyclosilicate (Lokelmaâ) during the 2-month treatment phase with the 3.0 K+/2.5 Ca++ dialysate bath will reduce the number of days outside the "K+ safety range" of 4.0 ... | [] |
NCT05535920 | 5.1.4 | Correlations Between Laboratory Parameters and Clinical Events | 5.1.4 Correlations Between Laboratory Parameters and Clinical Events The study will also evaluate the correlation between PBUTs (PCS, indoxyl sulfate, and ADMA) and the frequency of atrial fibrillation events, as well as the correlation between electrolyte levels and clinical events (intradialytic hypotension, muscle c... | [] |
NCT05535920 | 5.2 | Safety assessments | 5.2 Safety assessments | [] |
NCT05535920 | 5.2.1 | Laboratory safety assessments | 5.2.1 Laboratory safety assessments Blood samples for determination of select clinical chemistry parameters will be collected and analyzed as indicated in the Study Plan (see Table 1). As part of the safety objectives of the study, the number of hypokalemic events defined as Piccolo POCT or laboratory-measured K+ of < ... | [] |
NCT05535920 | 5.2.2 | Physical examination | 5.2.2 Physical examination As described in Section 4.1.5, at screening (prior to the placement of the implantable loop recorder), patients will undergo a complete physical examination that will focus on general appearance, respiratory and cardiovascular systems, and lower extremities, and will include a limited neurolo... | [] |
NCT05535920 | 5.2.3 | Cardiac Monitoring | 5.2.3 Cardiac Monitoring In this study, continuous cardiac recordings will be performed as part of efficacy evaluations throughout the two 8-week treatment phases, using the Medtronic insertable loop recorder (ILR, LINQ device). Insertion of the cardiac loop recorder is described in Section 4.1.8. Cardiac data recordin... | [] |
NCT05535920 | 5.2.3.1 | 12-lead ECG | 5.2.3.1 12-lead ECG As indicated in Section 4.1.7, Standard resting 12-lead ECG recording will be performed at Screening only and used for confirmation of eligibility. | [] |
NCT05535920 | 5.2.4 | Vital signs | 5.2.4 Vital signs As indicated in Section 4.1.6, measurement of vitals is standard of care throughout each dialysis session, and will include blood pressure, pulse, and body temperature. For information on how AEs based on vital signs measurements should be recorded and reported, see Section 6.4.6. | [] |
NCT05535920 | 5.2.5 | Other safety assessments – Concomitant Medications | 5.2.5 Other safety assessments – Concomitant Medications All concomitant medications taken by the subject from the time of their consent signature will be recorded; see Section 7.7. | [] |
NCT05535920 | 5.2.6 | Pregnancy Test for Females of Childbearing Potential | 5.2.6 Pregnancy Test for Females of Childbearing Potential As indicated in Section 4.1.4, a pregnancy test should be performed during screening for females of childbearing potential to confirm eligibility. | [] |
NCT05535920 | 5.3 | Safety Protocols | 5.3 Safety Protocols | [] |
NCT05535920 | 5.3.1 | Safety Protocol for Patients with Piccolo POCT-Confirmed Hypokalemia or Hyperkalemia | 5.3.1 Safety Protocol for Patients with Piccolo POCT-Confirmed Hypokalemia or Hyperkalemia Hyperkalaemia will be defined as a K+ > 7.0 mEq/L and measured using Piccolo POCT technology in pre-dialysis obtained after the long dialysis "weekend". Unless clinically unstable, patients with hyperkalaemia will be dialyzed and... | [] |
NCT05535920 | 5.3.2 | Safety Protocol for Patients with Intra-Dialytic Arrhythmias | 5.3.2 Safety Protocol for Patients with Intra-Dialytic Arrhythmias Patients developing clinically apparent dialysis-associated arrhythmia including atrial fibrillation with or without with rapid ventricular response (RVR), atrial tachycardia (defined as sustained pulse >130 bpm), bradycardia (defined a symptomatic puls... | [] |
NCT05535920 | 5.3.3 | Safety Protocol for Patients with Intra-Dialytic Hypotensive Events | 5.3.3 Safety Protocol for Patients with Intra-Dialytic Hypotensive Events All patients with a dialysis-associated hypotensive event (defined as a systolic blood pressure <90 mmHg) will be managed according to standard site unit protocols that may include: - a) The termination of all ultrafiltration - b) Administering a... | [] |
NCT05535920 | 5.3.4 | Safety Protocol for Patients with Intra-Dialytic Symptomatic Muscle Cramping | 5.3.4 Safety Protocol for Patients with Intra-Dialytic Symptomatic Muscle Cramping A "symptomatic episode of muscle cramping" is defined as an event associated with any of the following: - a) Requirement to lower the dialysis ultrafiltration rate - b) Requirement for a saline bolus - c) Patient request to terminate dia... | [] |
NCT05535920 | 5.4 | Pharmacokinetics | 5.4 Pharmacokinetics Not applicable. Pharmacokinetic samples will not be taken during the study. | [] |
NCT05535920 | 5.5 | Pharmacodynamics | 5.5 Pharmacodynamics Not applicable. Pharmacodynamic samples will not be taken during the study. | [] |
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