Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
Summary
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.
Timeline
- Start
- 2016-06-27
- Primary completion
- 2020-12-07
- Completion
- 2020-12-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Metformin vs Placebo; p = 0.50; Mean Difference (Net) 0.07 (95% CI -0.13 to 0.26); Mixed Models Analysis NCT02656017 ↗
registry analysis (superiority test); Metformin vs Placebo; p = 0.12; Gray's test NCT02656017 ↗
registry analysis (superiority test); Metformin vs Placebo; p = 0.98; Regression, Logistic NCT02656017 ↗
Publications
- 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.
- El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
- Seliger SL, Watnick T, Althouse AD, Perrone RD, Abebe KZ, Hallows KR, Miskulin DC, Bae KT. Baseline Characteristics and Patient-Reported Outcomes of ADPKD Patients in the Multicenter TAME-PKD Clinical Trial. Kidney360. 2020 Dec 31;1(12):1363-1372. doi: 10.34067/KID.0004002020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1000 mg | — |