protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05535920 | 5.6 | Pharmacogenetics | 5.6 Pharmacogenetics Not applicable. Pharmacogenetic samples will not be taken during the study. | [] |
NCT05535920 | 5.7 | Biomarker Analysis | 5.7 Biomarker Analysis Not applicable. There will be no collection and storage of donated biological samples for exploratory biomarker analysis. | [] |
NCT05535920 | 6 | SAFETY REPORTING AND MEDICAL MANAGEMENT | 6. SAFETY REPORTING AND MEDICAL MANAGEMENT The Principal Investigator is responsible for ensuring that all staff involved in the study are familiar with the content of this section. Please refer to section 4.2.2 and 5.1.2 for detail of how serious arrhythmias are detected and treated per the safety protocol and refer t... | [] |
NCT05535920 | 6.1 | Definition of Adverse Events | 6.1 Definition of Adverse Events An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be s... | [] |
NCT05535920 | 6.2 | Definitions of Serious Adverse Event | 6.2 Definitions of Serious Adverse Event A serious adverse event (SAE) is an AE occurring during any study phase (i.e., run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: - Results in death - Is immediately life-threatening - Requires in-patient hospitalization or prolongation o... | [] |
NCT05535920 | 6.3 | Definition of Suspected Unexpected Serious Adverse Event (SUSAR) | 6.3 Definition of Suspected Unexpected Serious Adverse Event (SUSAR) A suspected adverse reaction related to an Investigational Product (IP) that is both unexpected and serious. | [] |
NCT05535920 | 6.4 | Recording of adverse events | 6.4 Recording of adverse events | [] |
NCT05535920 | 6.4.1 | Time period for collection of adverse events | 6.4.1 Time period for collection of adverse events Adverse events will be collected from the time of first dose of Lokelmaâ, throughout the treatment and post-treatment follow-up period, up to the last study visit. SAEs will be reported from the time the patient signed the Informed Consent Form. | [] |
NCT05535920 | 6.4.2 | Follow-up of unresolved adverse events | 6.4.2 Follow-up of unresolved adverse events Any AEs that remain unresolved at the patient's last study visit will be followed up by the Investigator for as long as medically indicated, but without further recording in the eCRF. It is acknowledged that the Company may request additional information after the completion... | [] |
NCT05535920 | 6.4.3 | Variables | 6.4.3 Variables The following variables will be collected for each AE: - AE (verbatim) - The date when the AE started and stopped - Intensity Adverse Event intensity will be assessed according to the following categories: - o mild (awareness of sign or symptom, but easily tolerated) - o moderate (discomfort sufficient ... | [] |
NCT05535920 | 6.4.4 | Causality collection | 6.4.4 Causality collection The Investigator will assess causal relationship between the study drug and each AE, and answer 'yes' or 'no' to the question 'Do you consider that there is a reasonable possibility that the event may have been caused by the investigational product?' For SAEs, causal relationship will also be... | [] |
NCT05535920 | 6.4.5 | Adverse events based on signs and symptoms | 6.4.5 Adverse events based on signs and symptoms All AEs spontaneously reported by the subject or reported in response to the open question from study personnel: 'Have you had any health problems since your previous study visit?' or revealed by observation will be collected and recorded in the eCRF. It is preferred tha... | [] |
NCT05535920 | 6.4.6 | Adverse events based on examinations and tests | 6.4.6 Adverse events based on examinations and tests The results from protocol-mandated laboratory tests and vital signs measurements will be summarized in the clinical study report. Deterioration from baseline in protocol-mandated laboratory values or vital signs should therefore only be reported as AEs if they fulfil... | [] |
NCT05535920 | 6.5 | Reporting of serious adverse events to the IRB and/or the Regulatory Authority | 6.5 Reporting of serious adverse events to the IRB and/or the Regulatory Authority The Lokelma Package Insert serves as the Reference Safety Information (RSI) for this study. All SAEs occurring from the time of consent and during the study have to be reported, whether or not considered causally related to the study dru... | [] |
NCT05535920 | 6.6 | Reporting of Serious Adverse Events to Company | 6.6 Reporting of Serious Adverse Events to Company The Sponsor (NephroNet) is responsible for informing the Company (AstraZeneca) of all SAEs occurring during the study, whether or not considered causally related to the investigational product (IP). SAEs assessed as related to the IP must be provided to the Company on ... | [
"AEmailboxclinicaltrialTCS@astrazeneca.com"
] |
NCT05535920 | 6.7 | Overdose | 6.7 Overdose Overdose of the study drug (sodium zirconium cyclosilicate) (Lokelmaâ) could lead to hypokalemia. In case of suspected overdose (dosing above 15.0 g), potassium levels should be checked and potassium supplemented, as needed at the discretion of the PI. The Investigator or designated site personnel must inf... | [] |
NCT05535920 | 6.8 | Pregnancy | 6.8 Pregnancy All pregnancies and pregnancy outcomes should be reported to the Sponsor (NephroNet) and the Company (AstraZeneca) within the safety reporting guidelines. | [] |
NCT05535920 | 6.8.1 | Maternal exposure | 6.8.1 Maternal exposure If a patient becomes pregnant during the "high dialysate" treatment period, the study drug should be discontinued immediately. Pregnancy itself is not regarded as an adverse event. However, congenital abnormalities/birth defects and spontaneous miscarriages should be reported and handled as SAEs... | [] |
NCT05535920 | 6.8.2 | Paternal exposure | 6.8.2 Paternal exposure Not applicable. There will be no requirements or restrictions associated with paternal exposure. | [] |
NCT05535920 | 6.9 | Management of IP-related Toxicities / Dose Reductions | 6.9 Management of IP-related Toxicities / Dose Reductions The study drug (Lokelma) will be titrated from 5.0 grams per day (4 days/week) up to a maximum of 15.0 grams per day (4 days/week), to maintain K+ within the desired target range (between 4.0 and 5.5 mEq/L). potassium levels will be regularly monitored, and the ... | [] |
NCT05535920 | 6.10 | Study Governance and Oversight | 6.10 Study Governance and Oversight Responsibilities for the study design, protocol development, scientific oversight, and coordination of the study rest with the NephroNet as the responsible Academic Research Organization (ARO), and the National Coordinating PI (James A. Tumlin, MD). No study committees will be establ... | [] |
NCT05535920 | 7 | INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS | 7. INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS | [] |
NCT05535920 | 7.1 | Identity of Investigational Product(s) | 7.1 Identity of Investigational Product(s) The investigational product (IP) in this study is sodium zirconium cyclosilicate (Lokelmaâ), a potassium binder product for oral administration. It is indicated for the treatment of hyperkalemia in adults (Lokelma United States Prescribing Information [USPI], 19th October 2021... | [] |
NCT05535920 | 7.2 | Dose and Treatment Regimens | 7.2 Dose and Treatment Regimens | [] |
NCT05535920 | 7.2.1 | Dosing Regimen | 7.2.1 Dosing Regimen Patients will take Lokelma supplementation on off-dialysis days (4 days/week) while receiving hemodialysis with 3.0 K+/2.5 Ca++ mEq dialysate bath (8-week treatment phase): - Patients on a Monday-Wednesday-Friday dialysis schedule will take the study drug on Tuesday, Thursday, Saturday, and Sunday ... | [] |
NCT05535920 | 7.2.2 | Study Drug Dispensation and Instructions for Reconstitution and Dosing | 7.2.2 Study Drug Dispensation and Instructions for Reconstitution and Dosing The allow for adequate dosing (including dose-titration, as described in Section 7.2.1), the study drug will be dispensed to patients on a weekly basis, as follows: Table 3 IP Dispensing Schedule and Dosing Instructions | IP Dose Level | IP Pa... | [] |
NCT05535920 | 7.3 | Labelling | 7.3 Labelling Labels will be prepared in accordance with Good Manufacturing Practice (GMP) and local regulatory guidelines. The labels will fulfil GMP Annex 13 requirements for labelling. | [] |
NCT05535920 | 7.4 | Storage | 7.4 Storage All study drugs should be kept in a secure place under appropriate storage conditions, at a temperature between 15°C-30°C (59°F-86°F). The study drug label will specify the appropriate storage conditions. At the study site, study drug will be stored at the participating dialysis unit, separate from other si... | [] |
NCT05535920 | 7.5 | Compliance | 7.5 Compliance During the 8-week "high dialysate" treatment period, patients will be asked to return to the site all used (including empty) packets of study drug (Lokelma) on a weekly basis. These will be assessed by the study coordinator to confirm treatment compliance. In case of a discrepancy between the planned vs ... | [] |
NCT05535920 | 7.6 | Accountability | 7.6 Accountability The study drug (Lokelma) provided for this study will be used only as directed in this protocol. The study nurse coordinator will be responsible for recording all study drugs dispensed to and returned by the patient. Any unused packets of study drug will either be returned to the Company under the di... | [] |
NCT05535920 | 7.7 | Concomitant and Other Treatments | 7.7 Concomitant and Other Treatments All concomitant medications must be recorded in the appropriate sections of the eCRF. | [] |
NCT05535920 | 7.7.1 | Prohibited Treatment | 7.7.1 Prohibited Treatment Use of the following medications is prohibited during the study: | Prohibited Medication/Class of drug | Washout Period | | | |---------------------------------------------|----------------------------|--|--| | Amiodarone or other anti-arrhythmic therapy | 2 weeks prior to Screening | | | | P... | [] |
NCT05535920 | 7.7.2 | Other concomitant treatment | 7.7.2 Other concomitant treatment Other medication other than that described above, which is considered necessary for the subject's safety and well-being, may be given at the discretion of the Investigator, and recorded in the appropriate sections of the Case Report Form. The study drug (Lokelma) can transiently increa... | [] |
NCT05535920 | 7.8 | Post Study Access to Study Treatment | 7.8 Post Study Access to Study Treatment Not applicable. | [] |
NCT05535920 | 8 | STATISTICAL ANALYSES | 8. STATISTICAL ANALYSES | [] |
NCT05535920 | 8.1 | Statistical Considerations | 8.1 Statistical Considerations Analyses will be performed by the Sponsor or its representatives. A comprehensive Statistical Analysis Plan (SAP) may be prepared within 90 days of the date of the first participant enrolled, and any further changes during the course of the study will be included (reflecting the final Cli... | [] |
NCT05535920 | 8.2 | Sample Size Estimate | 8.2 Sample Size Estimate The primary statistical hypothesis of the study is that the rate of atrial fibrillation events during hemodialysis using the 3.0 K+ dialysate bath supplemented with sodium zirconium cyclosilicate (Lokelmaâ) is not equal to the rate of events incurred during hemodialysis using the 2.0 K+ dialysa... | [] |
NCT05535920 | 8.3 | Definitions of Analysis Sets and Analysis Periods | 8.3 Definitions of Analysis Sets and Analysis Periods The analysis of data will be based on different analysis sets according to the purpose of analysis, i.e., efficacy or safety. | [] |
NCT05535920 | 8.3.1 | All-participants Analysis Set | 8.3.1 All-participants Analysis Set The all-participants analysis set will consist of all participants who were screened for the study. | [] |
NCT05535920 | 8.3.2 | Full Analysis Set | 8.3.2 Full Analysis Set The Full Analysis Set (FAS) will include all randomized participants, with participants being analyzed as randomized, rather than as treated. All efficacy endpoints will be analyzed using the FAS. | [] |
NCT05535920 | 8.3.3 | Safety Analysis Set | 8.3.3 Safety Analysis Set The Safety Analysis Set will include all randomized participants who during the first treatment period (study Phase I): (i) received at least one dose of the study drug (Lokelma) during treatment with the 3.0 K+ dialysate bath; or (ii) completed Visit 2 during treatment with the 2.0 K+ dialysa... | [] |
NCT05535920 | 8.4 | Outcome Measures for Analyses | 8.4 Outcome Measures for Analyses | [] |
NCT05535920 | 8.4.1 | Primary Efficacy Endpoint: Frequency of Atrial Fibrillation Events | 8.4.1 Primary Efficacy Endpoint: Frequency of Atrial Fibrillation Events The primary efficacy endpoint is the frequency of atrial fibrillation events occurring during the 8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods. Atrial fibrillation will be defined as irregular heart rhythm... | [] |
NCT05535920 | 8.4.2 | Secondary Efficacy Endpoint #1: Frequency and duration of Clinically Significant Cardiac Arrhythmia Events | 8.4.2 Secondary Efficacy Endpoint #1: Frequency and duration of Clinically Significant Cardiac Arrhythmia Events Frequency and duration of CSCAs (bradycardia, ventricular tachycardia and/or asystole) events during the 8-week Phase-I dialysate cross-over period and the 8-week Phase-II cross-over period is a secondary ef... | [] |
NCT05535920 | 8.4.3 | Secondary Efficacy Endpoint #2: Events Outside the Optimal K+ "Window" | 8.4.3 Secondary Efficacy Endpoint #2: Events Outside the Optimal K+ "Window" The number of events of K+ outside of the 4.0 to 5.5 mEq/L safety range is a secondary efficacy endpoint in this study, The total number of events of pre- or post-dialysis K+ falling outside the "K+ safety range" will be averaged and compared ... | [] |
NCT05535920 | 8.4.4 | Exploratory Efficacy Endpoint #1:Relationship Between PBUTs and Atrial Fibrillation Rates | 8.4.4 Exploratory Efficacy Endpoint #1:Relationship Between PBUTs and Atrial Fibrillation Rates The study will also evaluate the correlation between PBUTs (indoxyl sulfate, PCS, and ADMA) and the frequency of atrial fibrillation events. | [] |
NCT05535920 | 8.4.5 | Exploratory Efficacy Endpoint #2: Correlation Between Electrolytes and Clinical Events | 8.4.5 Exploratory Efficacy Endpoint #2: Correlation Between Electrolytes and Clinical Events The following correlations will be explored: - Ø Correlation between electrolyte levels and clinical events (intradialytic hypotension, muscle cramping, and cardiac arrhythmias). - Ø Correlation between electrolytes falling bel... | [] |
NCT05535920 | 8.4.6 | Safety Endpoint #1: Lokelma Induced Hypokalemia | 8.4.6 Safety Endpoint #1: Lokelma Induced Hypokalemia To evaluate whether the use of Lokelma during periods when patients are receiving a 3.0 K+/2.5 Ca++ bath is associated with hypokalemic events, the total number of hypokalemic events (defined as Piccolo POCT or laboratory-measured K+ of < 3.5 mEq/L) will be summariz... | [] |
NCT05535920 | 8.4.7 | Safety Endpoint #2: Incidence of Dialysis-related Hypokalemia, Hypomagnesemia, Hypophosphatemia, or Low Calcium | 8.4.7 Safety Endpoint #2: Incidence of Dialysis-related Hypokalemia, Hypomagnesemia, Hypophosphatemia, or Low Calcium This endpoint is defined as the number of events promptly prior to the termination of dialysis where a Piccolo POCT measurement of K+ is < 2.0 mEq/L OR Ca++ is < 7.0 mEq/L, OR Mg++ is < 2.0 mg/dl OR a P... | [] |
NCT05535920 | 8.4.8 | Safety Endpoint #3: Adverse Experiences | 8.4.8 Safety Endpoint #3: Adverse Experiences The frequencies of AEs, SAEs, and withdrawals due to AEs will be summarized, with focus on treatment-related events. | [] |
NCT05535920 | 8.5 | Methods for statistical analyses | 8.5 Methods for statistical analyses This section is a summary of the planned statistical analyses of the most important endpoints including primary and secondary endpoints. | [] |
NCT05535920 | 8.5.1 | General Considerations | 8.5.1 General Considerations Inference concerning the primary analysis will be performed at the 2-sided 5% significance level. All point estimates will be presented together with confidence intervals of 2-sided 95% coverage. The analysis assumes that there is no carry-over effect given that the wash-out period is deeme... | [] |
NCT05535920 | 8.5.1.1 | COVID Considerations | 8.5.1.1 COVID Considerations It is anticipated that additional sensitivity and supplementary analyses will be required to determine the impact of the COVID-19 pandemic on this trial and its endpoints. Planned sensitivity analyses will distinguish between pandemic and non-pandemic-related intercurrent events in terms of... | [] |
NCT05535920 | 8.5.2 | Analysis of the Primary Variable | 8.5.2 Analysis of the Primary Variable The primary efficacy endpoint is the frequency of atrial fibrillation events occurring during the 8-week Treatment Phase-1 and the 8-week Treatment Phase-2 dialysate cross-over periods. The primary analysis will test the null hypothesis that there is no difference in the rate of a... | [] |
NCT05535920 | 8.5.3 | Analysis of the Secondary Variables | 8.5.3 Analysis of the Secondary Variables Each secondary endpoint will be analyzed individually, and no multiplicity control will be applied. Analyses of secondary variables will not account for missing values. The secondary endpoint of clinically significant arrhythmia events will be analyzed similarly to the primary ... | [] |
NCT05535920 | 8.5.4 | Analysis of the Exploratory Variables | 8.5.4 Analysis of the Exploratory Variables All exploratory endpoints will be analysed using the FAS. A full description of the exploratory endpoints and analyses will be included in the SAP. | [] |
NCT05535920 | 8.5.5 | Subgroup analysis | 8.5.5 Subgroup analysis The primary and select secondary variables may be analyzed based on the following pre-defined subgroups: 1) ESRD patients with diabetes mellitus: Patients with diabetic nephropathy as their proximate cause of ESRD will be pre- identified as a group of patients with increased risk for post-dialys... | [] |
NCT05535920 | 8.5.6 | Safety Analyses | 8.5.6 Safety Analyses Lokelma-induced hypokalemia will be evaluated based on the total number of hypokalemic events defined as Piccolo POCT or laboratory-measured K+ of < 3.5 mEq/L. The incidence of dialysis-related hypokalemia, hypomagnesemia, hypophosphatemia, and low calcium will be evaluated based on the number of ... | [] |
NCT05535920 | 8.5.7 | Interim analysis | 8.5.7 Interim analysis No interim analysis is planned. | [] |
NCT05535920 | 9 | STUDY AND DATA MANAGEMENT | 9. STUDY AND DATA MANAGEMENT | [] |
NCT05535920 | 9.1 | Training of study site personnel | 9.1 Training of study site personnel Before the first patient is entered into the study, a Sponsor representative will review and discuss the requirements of the Clinical Study Protocol and related documents with the investigational staff and train them in any study-specific procedures. The site PI will ensure that app... | [] |
NCT05535920 | 9.2 | Monitoring of the study | 9.2 Monitoring of the study Site management and monitoring will be the responsibility of the Sponsor (NephroNet). During the study, a Sponsor representative will have regular contacts with the study sites, including visits to: - Provide information and support to the Investigator(s) - Confirm that facilities remain acc... | [] |
NCT05535920 | 9.2.1 | Source data | 9.2.1 Source data Refer to the Research Agreement for location of source data. | [] |
NCT05535920 | 9.2.2 | Research Agreement(s) | 9.2.2 Research Agreement(s) Site PIs should comply with all the terms, conditions, and obligations of the Research Agreement, or equivalent, for this study. In the event of any inconsistency between this Clinical Study Protocol and the Research Agreement, the terms of the Clinical Study Protocol shall prevail with resp... | [] |
NCT05535920 | 9.2.3 | Archiving of study documents | 9.2.3 Archiving of study documents The Sponsor follows the principles outlined in the Research Agreement (RA). The study site/site PI will retain the essential documents specified in the Good Clinical Practice (GCP), guidelines of the International Conference on Harmonisation (ICH) (e.g., source document such as medica... | [] |
NCT05535920 | 9.2.4 | Deviation from the clinical study protocol | 9.2.4 Deviation from the clinical study protocol The Investigator(s) must not deviate from or make any changes to the protocol without documented approval from the Sponsor and the reviewing IRB, except in case of a medical emergency, where the deviation or change is necessary to avoid an immediate hazard to study patie... | [] |
NCT05535920 | 9.3 | Study Timetable and End of Study | 9.3 Study Timetable and End of Study The end of the study is defined as Last Patient Last Visit (LPLV). The study is expected to start in April 2022 and to end by end of June 2023. The study may be terminated at individual centers if the study procedures are not being performed according to GCP, or if recruitment is sl... | [] |
NCT05535920 | 9.4 | Data Management | 9.4 Data Management Data management activities will be performed by according to the Data Management Plan. Adverse events and medical/surgical history will be classified according to the terminology of the latest version the Medical Dictionary for Regulatory Activities (MedDRA). Medications will be classified according... | [
"Serious Adverse Event (SAE) Reconciliation",
"Management of external data"
] |
NCT05535920 | 10 | ETHICAL AND REGULATORY REQUIREMENTS | 10. ETHICAL AND REGULATORY REQUIREMENTS | [] |
NCT05535920 | 10.1 | Ethical Conduct of the Study | 10.1 Ethical Conduct of the Study The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, and applicable regulatory requirements. | [] |
NCT05535920 | 10.2 | Patient Data Protection | 10.2 Patient Data Protection The Informed Consent Form will incorporate (or, in some cases, be accompanied by a separate document incorporating) wording that complies with relevant data protection and privacy legislation. Patients will be informed that all study data will be stored in secure password-protected computer... | [] |
NCT05535920 | 10.3 | Ethics and Regulatory Review | 10.3 Ethics and Regulatory Review | [] |
NCT05535920 | 10.3.1 | Ethics Review | 10.3.1 Ethics Review Appropriate written IRB approval must be obtained for the final study protocol and Informed Consent Form, as well as any other written information and/or materials to be provided to study patients (e.g., advertising used to recruit patients for the study). The site PI will be responsible for submit... | [] |
NCT05535920 | 10.3.2 | Regulatory Review | 10.3.2 Regulatory Review The National Coordinating PI (James A. Tumlin, MD) submitted the Investigational New Drug (IND) application to the FDA, and the FDA ruled that this study is IND exempt. | [] |
NCT05535920 | 10.4 | Informed consent | 10.4 Informed consent Investigators will ensure that: - Each patient is given full and adequate oral and written information about the nature, purpose, possible risks, and benefits of the study - Each patient is explained that they are free to discontinue from the study at any time - Each patient is given the opportuni... | [] |
NCT05535920 | 10.5 | Changes to the protocol and informed consent form | 10.5 Changes to the protocol and informed consent form Study procedures will not be changed without approval from the Sponsor. If there are any substantial changes to the study protocol, these changes will be documented in a study protocol amendment. The amendment is to be approved by the relevant IRB. The Sponsor will... | [] |
NCT05535920 | 10.6 | Audits and inspections | 10.6 Audits and inspections Authorized representatives of the Sponsor, a regulatory agency, or an IRB may perform site audits or inspections, including source data verification. The purpose of an audit or inspection is to systematically and independently examine all study-related activities and documents, to determine ... | [] |
NCT05535920 | 11 | LIST OF REFERENCES | 11. LIST OF REFERENCES Airy M, Schold JD, Jolly SE, et al. Cause-Specific Mortality in Patients with Chronic Kidney Disease and Atrial Fibrillation. Am J Nephrol. 2018;48(1):36-45. doi:10.1159/000491023 Aoki K, Teshima Y, Kondo H, et al. Role of Indoxyl Sulfate as a Predisposing Factor for Atrial Fibrillation in Renal ... | [
"Appendix A Additional Safety Information",
"Further Guidance on the Definition of a Serious Adverse Event (SAE)",
"Life threatening",
"Hospitalization",
"Important medical event or medical intervention",
"Examples:"
] |
NCT05535920 | A | Guide to Interpreting the Causality Question | A Guide to Interpreting the Causality Question When assessing causality, consider the following factors when deciding if there is a 'reasonable possibility' that an AE may have been caused by the drug: - Exposure to suspect drug: Has the patient actually received the suspect drug? - Time Course: Did the AE occur in a r... | [
"Appendix B International Airline Transportation Association (IATA) 6.2 Guidance Document",
"Appendix C Pharmacogenetics Research"
] |
NCT05584657 | 1 | INTRODUCTION | 1 INTRODUCTION | [] |
NCT05584657 | 1.1 | Indication | 1.1 Indication Sulopenem and/or sulopenem etzadroxil/probenecid (oral sulopenem) are being studied for the treatment of the following indications: - Uncomplicated urinary tract infections - Complicated urinary tract infections - Complicated intra-abdominal infections | [] |
NCT05584657 | 1.2 | Background and Rationale | 1.2 Background and Rationale β-lactam antimicrobials are widely recognized for their efficacy and low toxicity and form the cornerstone of therapy for the treatment of infections caused by gram-positive and gram-negative bacteria. However, extensive use of β-lactams during the past 50 years has resulted in the developm... | [
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0",
"Study IT001-301:",
"Study IT001-302:",
"Study IT001-303:",
"Rationale for amoxicillin/clavulanate as the comparator:",
"Pre-clinical data",
"Previous human experience",
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0",
... |
NCT05584657 | 1.2.2 | Rationale for Study | 1.2.2 Rationale for Study ß-lactam antimicrobials are widely recognized for their efficacy and low toxicity and form the cornerstone of therapy for the treatment of infections caused by gram-positive and gram-negative bacteria. However, extensive use of ß-lactams during the past 50 years has resulted in the development... | [
"IT001-310 Protocol Amendment 1 12-5-2022 | VV-TMF-165994 | 1.0",
"Rationale for probenecid",
"Rationale for dosing with food"
] |
NCT05584657 | 1.2.3 | Dose Rationale | 1.2.3 Dose Rationale
Sulopenem etzadroxil Doses of oral sulopenem etzadroxil were chosen by PK/PD modeling using a combination of (1) modeling (Naïve Pool analysis) of the sulopenem effect on net change in colony forming units (CFU) over 24 hours of clinically relevant organisms in an immunocompetent mouse thigh infec... | [
"Sulopenem etzadroxil",
"Probenecid",
"Amoxicillin/clavulanate"
] |
NCT05584657 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES | [] |
NCT05584657 | 2.1 | Objectives | 2.1 Objectives | Non-inferiority Trial: | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT05584657 | 3 | STUDY DESIGN | 3 STUDY DESIGN Study IT001-310 is a prospective, Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem to oral amoxicillin/clavulanate for the treatment of patients with uUTI. Approximately 1966 adult women with uUTI will be randomized in a 1:1 fashion to receive eithe... | [] |
NCT05584657 | 3.1 | Investigational Study Medications | 3.1 Investigational Study Medications Patients will be randomized to receive either a bilayer tablet with sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days or amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days. Sulopenem etzadroxil treatment group: The study drug will be supplied as a... | [] |
NCT05584657 | 3.2 | Adjunctive Systemic Antibiotics | 3.2 Adjunctive Systemic Antibiotics None allowed except as described in Section 5.4.2. | [] |
NCT05584657 | 3.3 | Additional Non-Study Therapy Antibiotics | 3.3 Additional Non-Study Therapy Antibiotics For Clostridioides difficile infections, metronidazole (IV or oral), vancomycin (oral or rectal), or fidaxomicin (oral) may be used in both treatment groups. Patients with a co-infection with a gram-positive uropathogen known or suspected to be resistant to study drugs are a... | [] |
NCT05584657 | 4 | STUDY POPULATION SELECTION | 4 STUDY POPULATION SELECTION Female patients who present with uUTI, defined by symptoms and a urinalysis suggestive of a uUTI per Section 4.1, and who meet all of the inclusion and none of the exclusion criteria will be eligible for participation in this study. This study can fulfill its objectives only if appropriate ... | [] |
NCT05584657 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria - 1. Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI - 2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain. - 3. A mid-stream urine specimen with: - a. a mac... | [] |
NCT05584657 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria - 1. Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting - 2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior... | [] |
NCT05584657 | 4.3 | Randomization Criteria | 4.3 Randomization Criteria Patients will be randomized in a 1:1 ratio to oral sulopenem versus oral amoxicillin/clavulanate using an IWRS into the study provided they have satisfied all patient selection criteria. | [] |
NCT05584657 | 4.4 | Lifestyle Guidelines | 4.4 Lifestyle Guidelines For the duration of the study, all female patients of child-bearing potential must agree to be strictly abstinent from sexual intercourse with any individual of the opposite sex, or to follow the following instructions for contraception. | [] |
NCT05584657 | 4.5 | Women of Child-Bearing Potential | 4.5 Women of Child-Bearing Potential If the patient is a woman of childbearing potential (women of child-bearing potential and peri-menopausal women include females <50 years of age or those ≥ 50 years of age who have been post-menopausal [amenorrheic] for < 2 years) , and not practicing abstinence, that patient is req... | [] |
NCT05584657 | 5 | STUDY TREATMENTS | 5 STUDY TREATMENTS | [] |
NCT05584657 | 5.1 | Allocation to Treatment | 5.1 Allocation to Treatment This is a randomized, double-blind, double dummy, controlled study comparing oral sulopenem with oral amoxicillin/clavulanate in the treatment of uUTI. Approximately 1966 patients will be randomized to receive either oral sulopenem twice daily for 5 days or oral amoxicillin/clavulanate twice... | [] |
NCT05584657 | 5.2 | Drug Supplies | 5.2 Drug Supplies | [] |
NCT05584657 | 5.2.1 | Formulation and Packaging | 5.2.1 Formulation and Packaging Sulopenem etzadroxil/probenecid treatment group: The study drug will be supplied as a study kit containing one bottle with 10 bilayer tablets containing sulopenem etzadroxil/probenecid 500 mg/500 mg and one blister wallet containing 10 amoxicillin/clavulanate placebo capsules. Patients f... | [] |
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