Rationale and design of the Renal Lifecycle Trial assessing the Effect of Dapagliflozin on Cardiorenal Outcomes in Severe Chronic Kidney Disease.

Background: Several clinical trials have shown beneficial effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on kidney disease progression and cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) with and without type 2 diabetes mellitus. However, some subgroups of patients with CKD have been excluded from participation in these trials, such as patients with severely impaired kidney function, patients on dialysis, and kidney transplant recipients.

Methods: The Renal Lifecycle trial (NCT05374291) is a pragmatic, international, multicenter, investigator-initiated, randomized, placebo-controlled, clinical trial planned to enroll approximately 1500 patients with 1) an estimated glomerular filtration rate (eGFR) ≤25 ml/min/1.