Phase 3Active, not recruiting
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe Chronic Kidney Disease
- Sponsor
- University Medical Center Groningen (Academic or other)
- Enrolment
- 1,750 planned
- Conditions
- Kidney Disease, Chronic; Renal Transplant Failure; Heart Failure; Kidney Failure; Death
- Interventions
- Dapagliflozin 10 mg/day (oral); Placebo
- Ages
- adults, older adults
- Registry
- NCT05374291, CTIS2023-508389-13-00, EUCTR2021-005446-15
Full record on ClinicalTrials.gov
From the registry
Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup…
Primary outcomes
- Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure
History
Primary completion expected
Last registry update
Started
Registered