This information is intended for healthcare professionals to learn more about the Renal Lifecycle study.

Name

A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Severe Chronic Kidney Disease.

Abbreviated name

The Renal Lifecycle trial

Trial registration

The Renal Lifecycle trial is registered with ClinicalTrials.gov under number NCT5374291 and in EudraCT under number 2021-005446-15. 

Chronic kidney disease

Chronic kidney disease (CKD) is a common condition, affecting approximately 10% of the world’s population. It is diagnosed and monitored by blood and urine tests. CKD has many causes, the most common being diabetes, high blood pressure and chronic glomerulonephritis. People with chronic kidney disease are known to be at increased risk for complications including cardiovascular disease, heart failure, and end-stage renal failure requiring renal replacement therapy.

Rationale

For several years, a new class of drugs called SGLT2 inhibitors has been in use. The investigational drug dapagliflozin also belongs to this class. These are drugs recommended for the treatment of diabetes, cardiovascular and renal diseases. The use of these drugs is approved by European (EMA) and Dutch (CBG) governments.

Previous large studies have shown several positive effects of SGLT2 inhibitors, including a decrease in the amount of protein in urine and protection against the development of kidney and heart failure. In addition, SGLT2 inhibitors were well tolerated and proved safe. The studies conducted so far did not include patients with poor renal function (a renal function of less than 25 ml/min/1.73 m2, dialysis patients and kidney transplant recipients). This is very unfortunate, as these patients in particular are at increased risk for the aforementioned complications. There is increasing evidence from animal studies and retrospective analyses of large clinical trials that SGLT2 inhibitors may also be effective in preventing renal failure, heart failure and death in patients with severe kidney disease, including dialysis and kidney transplant patients. Therefore, this trial examines whether and how SGLT2 inhibitors work on heart and kidney failure in patients with severe kidney disease, including dialysis and kidney transplant patients.