drugset / Trial / NCT04794517
Dapagliflozin in Non-diabetic Stage IV CKD
Phase 2
Completed
32 enrolled
Mario Negri Institute for Pharmacological Research
AstraZeneca · collab
RandomizedCrossoverDouble-blindTreatment
Summary
This is a phase 2b, prospective, randomized, cross-over, double-blind, placebo-controlled trial primarily aimed at assessing whether the SGLT2 inhibitor dapagliflozin ameliorates hyperfiltration and reduces proteinuria as compared to placebo in patients with non-diabetic CKD, with particular focus on those at highest risk of progression to end stage kidney disease (ESKD) because of severe renal insufficiency (Stage IV CKD) and proteinuria (\>0.5 g/24 hours). The study will also evaluate renal and systemic mechanisms mediating treatment effects on GFR and will explore biochemical factors possibly mediating these effects.
Timeline
- Start
- 2021-11-08
- Primary completion
- 2024-05-07
- Completion
- 2024-05-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |