drugset / Trial / NCT05510115
Feasibility of Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease
Phase 2
Active not recruiting
50 enrolled
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabUniversity of Maryland · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigator proposes a pilot randomized clinical trial to determine the safety and tolerability of empagliflozin in ADPKD patients. To achieve this, the investigator will conduct a 12-month parallel-group, randomized, double-blind, placebo-controlled trial in 50 ADPKD patients with an eGFR 30-90 mL/min/1.73m2.
Timeline
- Start
- 2022-11-18
- Primary completion
- 2026-03-18
- Completion
- 2026-08-01
Publications
- Eswarappa M, Madden E, Shlipak MG, Cui X, Mrug M, Estrella MM, Park M. Sodium-Glucose Cotransporter-2 Inhibitor Therapy and Longitudinal Changes in Kidney Function among Veterans with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 May 16;20(7):940-949. doi: 10.2215/CJN.0000000725.
- 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.
- Hogan MC, Simmons K, Ullman L Jr, Gondal M, Dahl NK. Beyond Loss of Kidney Function: Patient Care in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2023 Dec 1;4(12):1806-1815. doi: 10.34067/KID.0000000000000296. Epub 2023 Nov 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | — |
| Subject | Empagliflozin | Small molecule | 25 mg | — |