NCT03273413Active, not recruitingPhase 4
Statin Therapy in Patients With Early Stage ADPKD
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 1 Sept 2017
- Start date
- 31 Aug 2017
- Primary completion date
- 25 Mar 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Polycystic kidney disease
- NCT number
- NCT03273413
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 150
- From 31 Aug 2017 to the primary completion date, 25 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior ischemic stroke
- Immunosuppressive therapy within the last year
- Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
Other illness
- Uncontrolled hypertension
- Diabetes mellitus
- Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
- Unstable angina
- Coronary artery disease
- History of hospitalizations within the last 3 months
- Hepatic impairment or liver function abnormalities
- Hypersensitivity to statins
- Hypersensitivity to iodine
Other
- Other clinical indication for a statin
- Secondary hypercholesterolemia or hypocholesterolemia
- Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
- Pregnant or breast feeding
- Current tobacco use
- Alcohol abuse or dependence
Who the study is looking for
- Diagnosis of ADPKD
- Total kidney volume \>500 mL
- Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73m\^2
- Controlled blood pressure \<140/80 mmHg
Age in the registry: 25 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver | Anschutz Medical Campus Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
Related publications
- A randomized controlled trial evaluated the effect of pravastatin on kidney disease outcomes in adult patients with early-stage autosomal dominant polycystic kidney disease.Kidney Int · 2026 · PMID 41077128
- Statin therapy in patients with early-stage autosomal dominant polycystic kidney disease: Design and baseline characteristics.Contemp Clin Trials · 2024 · PMID 38151173
This page is information, not medical advice. Discuss any trial with your doctor.