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NCT02855268 · ClinicalTrials.gov registry record · Phase 2
Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02855268 is a Phase 2 study that was terminated before completion, run by Genzyme, a Sanofi Company. The registered enrollment target is 43 participants.
The verdict
NCT02855268, a Phase 2 study, was terminated before completion, sponsored by Genzyme, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
Primary Objectives: * To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function. * To assess the safety and tolerability of lademirsen (SAR339375) in participants with Alport syndrome. Secondary Objectives: * To assess plasma pharmacokinetic (PK) parameters of the parent compound and its active major metabolite. * To assess the potential formation of anti-drug antibodies (ADAs) following administration of lademirsen (SAR339375). * To assess the pharmacodynamic effect of lademirsen (SAR339375) on miR-21 and on changes in renal injury and function biomarkers.
Interventions
- DRUG Placebo
- DRUG lademirsen (SAR339375)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-11-02 |
| Est. Completion | 2022-09-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02855268
The ClinicalTrials.gov registry entry for NCT02855268 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02855268 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02855268 about?
NCT02855268 is a clinical study titled "Study of Lademirsen (SAR339375) in Patients With Alport Syndrome". Primary Objectives: * To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function. * To assess the safety and tolerability of lademirsen (SAR339375) in participants with Alport syndrome. Secondary Objectives: * To assess plasma pharmacokinetic (PK) parameters of the...
What is the current status of trial NCT02855268?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-11-02. Estimated completion is 2022-09-22.
What interventions are being tested in trial NCT02855268?
The interventions under investigation include: Placebo (DRUG), lademirsen (SAR339375) (DRUG).
Who is sponsoring clinical trial NCT02855268?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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