Statin Therapy in Patients With Early Stage ADPKD
- Conditions
- Autosomal Dominant Polycystic KidneyADPKD
- Interventions
- Drug: Placebo
- Registration Number
- NCT03273413
- Lead Sponsor
- University of Colorado, Denver
- 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 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.
- 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 kidney magnetic resonance imaging (MRI); 2) renal blood flow as measured by kidney magnetic resonance angiography (MRA); 3) kidney function as assessed by Glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in ADPKD; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. These parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with ADPKD.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive inactive 40 mg tablets of placebo everyday for 6 weeks. If well tolerated, participants will continue taking inactive 40 mg dose of placebo everyday for 2 years. Pravastatin Pravastatin Participants will receive 40 mg tablets of pravastatin everyday for 6 weeks. If well tolerated, participants will continue taking 40 mg dose of pravastatin everyday for 2 years.
- Primary Outcome Measures
Name Time Method Change in Total Kidney Volume Baseline, 2 years Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment
- Secondary Outcome Measures
Name Time Method Change in Circulating Inflammatory Markers Baseline, 2 years Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment
Change in Renal Blood Flow Baseline, 2 years Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment
Change in Kidney Function Baseline, 2 years Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment
Change in Circulating Markers of Oxidative Stress Baseline, 2 years Plasma levels of oxidative stress markers at baseline and after 2 years of treatment
Change in Urinary Epithelial Cells Baseline, 2 years Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment
Trial Locations
- Locations (1)
University of Colorado Denver Anschutz Medical Campus
🇺🇸Denver, Colorado, United States