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NCT03273413 · ClinicalTrials.gov registry record · Phase 4
Statin Therapy in Patients With Early Stage ADPKD
A Phase 4 study of Autosomal Dominant Polycystic Kidney and ADPKD, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT03273413: Active Phase 4 study of Autosomal Dominant Polycystic Kidney and ADPKD, sponsored by University of Colorado, Denver.
NCT03273413 is a Phase 4 study of Autosomal Dominant Polycystic Kidney and ADPKD that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 150 participants, above the 80-participant average among 6 other Autosomal Dominant Polycystic Kidney trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03273413, a Phase 4 study of Autosomal Dominant Polycystic Kidney and ADPKD, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.
Primary Outcome
Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pravastatin
Study Locations (1)
Colorado
- University of Colorado Denver Anschutz Medical Campus - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 4 |
What the registry record for NCT03273413 still lists
NCT03273413 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 6 other Autosomal Dominant Polycystic Kidney trials with a reported enrollment target (88% higher).
The record links to 2 conditions, with Autosomal Dominant Polycystic Kidney appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03273413 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03273413 about?
NCT03273413 is a clinical study titled "Statin Therapy in Patients With Early Stage ADPKD". This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high choleste...
What is the current status of trial NCT03273413?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2017-08-31. Estimated completion is 2025-09-30.
What conditions does trial NCT03273413 study?
This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney, ADPKD.
What interventions are being tested in trial NCT03273413?
The interventions under investigation include: Placebo (DRUG), Pravastatin (DRUG).
Who is sponsoring clinical trial NCT03273413?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03273413 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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