The RENAL LIFECYCLE trial: A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Severe Chronic Kidney Disease

Phase 3

Recruiting

• Conditions: Hemo- and peritoneal dialysis patients; Transplant patients; severe CKD; renal failure; 10029149

• Registration Number: NL-OMON56031
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

In order to be eligible to participate in the randomized controlled double
blind trial subject must meet the criteria for one of the three strata:
• Patients with advanced CKD i.e. an eGFR <=25 mL/min/1.73m2
• Hemo- and peritoneal dialysis patients with a residual diuresis >=500 mL/24h
(at least 3 months after start of dialysis)
• Transplant patients with an eGFR <=45 mL/min/1.73m2 (at least 6 months after
transplantation)

In addition, to be eligible all subjects must meet all criteria below
• Age >18 years
• Willing to sign informed consent
• Pre-dialysis patients with eGFR <=25 mL/min/1.73m2 have to be on a stable dose
(no changes in dose or type of drug) of ACEis or ARBs for at least 4 weeks
prior to the screening visit to be eligible to proceed to the randomization
visit unless there is documented evidence that the patient does not tolerate an
ACEi or ARB. These subjects will maintain their stable doses of ACEis or ARBs
throughout the trial (when possible and tolerated by the patient). ACEi or ARBs
are not required for patients on maintenance dialysis or kidney transplant
recipients.

Exclusion Criteria

• Mentally incapacitated subjects (i.e. not able to sign informed consent)
• Diagnosis of type 1 diabetes mellitus
• Concurrent treatment with SGLT2 inhibitor
• History of >=2 urinary tract / genital infections during the last six months
• Life expectancy <6 months in the opinion of the treating physician.
• Scheduled start of dialysis within 3 months or scheduled kidney
transplantation within 6 months
• In patients with an eGFR <=25 mL/min/1.73m2: kidney disease treated with
immunosuppressive agents during the last 6 months
• patients treated during the last 6 months with a course of immunosuppressive
agents or intensification of treatment with immunosuppressive agents, such as
patients with a kidney transplant and acute rejection or patients with GPA
(Morbus Wegener) and a recent flare.
• Active malignancy aside from treated squamous cell or basal cell carcinoma of
the skin.
• History of severe hypersensitivity or known severe hepatic impairment
(Child-Pugh class C)
• History of severe noncompliance to medical regimens or unwillingness to
comply with the study protocol.
• Current pregnancy, lactation or women of child-bearing potential
(WOCBP) unless using highly-effective contraceptive
measurements until 4 weeks after last intake of the study medication
• Presence of other transplanted organ besides a kidney transplant
• Severe lactose intolerance
• Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with
tolvaptan

Study & Design

• Study Type: Interventional
• Study Design: Not specified