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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pravastatin | Drug | Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Kidney Volume | Total kidney volume as assessed by renal MRI, at baseline and after 2 years of treatment | Baseline, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Renal Blood Flow | Renal blood flow, as assessed by renal MRA, at baseline and after 2 years of treatment | Baseline, 2 years |
| Change in Kidney Function | Glomerular filtration rate (GFR), as assessed by Glofil-125, at baseline and after 2 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Vessel Stiffness | Blood vessel stiffness, as assessed by carotid-femoral pulse wave velocity, at baseline and after 2 years | Baseline, 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Chonchol, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Denver | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24721893 | Background | Cadnapaphornchai MA, George DM, McFann K, Wang W, Gitomer B, Strain JD, Schrier RW. Effect of pravastatin on total kidney volume, left ventricular mass index, and microalbuminuria in pediatric autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2014 May;9(5):889-96. doi: 10.2215/CJN.08350813. Epub 2014 Apr 10. | |
| 41077128 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2026 | Feb 19, 2026 | 10 | ||
| May 28, 2026 |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, double-blind, placebo-controlled, parallel study design.
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| Placebo |
| Drug |
Inactive tablet |
|
| Baseline, 2 years |
| Change in Circulating Inflammatory Markers | Plasma levels of inflammatory cytokines and growth factors at baseline and after 2 years of treatment | Baseline, 2 years |
| Change in Circulating Markers of Oxidative Stress | Plasma levels of oxidative stress markers at baseline and after 2 years of treatment | Baseline, 2 years |
| Change in Urinary Epithelial Cells | Urinary epithelial cell protein expression, as assessed by immunofluorescence, at baseline and after 2 years of treatment | Baseline, 2 years |
| Gitomer BY, Ostrow A, Wang W, George D, Coleman E, Nowak KL, Cadnapaphornchai MA, Patel NU, Steele C, Jovanovich A, Klawitter J, Farmer B, You Z, Chonchol M. 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 Feb;109(2):390-397. doi: 10.1016/j.kint.2025.08.037. Epub 2025 Oct 10. |
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. |
| 38151173 | Derived | Gitomer BY, Wang W, George D, Coleman E, Nowak KL, Struemph T, Cadnapaphornchai MA, Patel NU, Jovanovich A, Klawitter J, Farmer B, Ostrow A, You Z, Chonchol M. Statin therapy in patients with early-stage autosomal dominant polycystic kidney disease: Design and baseline characteristics. Contemp Clin Trials. 2024 Feb;137:107423. doi: 10.1016/j.cct.2023.107423. Epub 2023 Dec 25. |
| Jun 23, 2026 |
| 11 |
| Jun 29, 2026 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |