Status:
ACTIVE_NOT_RECRUITING
Statin Therapy in Patients With Early Stage ADPKD
Lead Sponsor:
University of Colorado, Denver
Conditions:
ADPKD
Autosomal Dominant Polycystic Kidney
Eligibility:
All Genders
25-60 years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with ADPKD by evaluating 1) kidney volume as measured by kidn...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Uncontrolled hypertension
- Diabetes mellitus
- Renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury
- Unstable angina
- Coronary artery disease
- Prior ischemic stroke
- Other clinical indication for a statin
- History of hospitalizations within the last 3 months
- Hepatic impairment or liver function abnormalities
- Secondary hypercholesterolemia or hypocholesterolemia
- Use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine
- Hypersensitivity to statins
- Immunosuppressive therapy within the last year
- Clinical contraindication for an MRI (i.e. implants, pacemaker, claustrophobia)
- Hypersensitivity to iodine
- Pregnant or breast feeding
- Current tobacco use
- Alcohol abuse or dependence
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03273413
Start Date
August 31 2017
End Date
September 30 2025
Last Update
May 8 2025
Active Locations (1)
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1
University of Colorado Denver Anschutz Medical Campus
Denver, Colorado, United States, 80045