ADPKD, Autosomal Dominant Polycystic Kidney
Conditions
Keywords
Pravastatin, Statin
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.
Interventions
DRUGPravastatin
Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy
DRUGPlacebo
Inactive tablet
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled, parallel study design.
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in Circulating Inflammatory Markers | Baseline, 2 years | Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Vessel Stiffness | Baseline, 2 years | Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years |
Countries
United States
Outcome results
None listed