Statin Therapy in Patients With Early Stage ADPKD

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.

Timeline

Start

2017-08-31

Primary completion

2024-03-25

Completion

2025-09-30

Publications

• 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.
• 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.
• 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.
• 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.

Drugs

Indications