Status:
ENROLLING_BY_INVITATION
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
AstraZeneca
Dutch Kidney Foundation
Conditions:
Kidney Disease, Chronic
Renal Transplant Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 sin...
Detailed Description
Objective: To establish the reno- and cardioprotective efficacy and safety of dapagliflozin in patients with severe CKD Study design: Multicenter, randomized, controlled, double blinded, pragmatic,...
Eligibility Criteria
Inclusion
- Patients with advanced CKD i.e. an eGFR ≤25 mL/min/1.73m2
- Dialysis patients (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
- 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 kidney transplantation within 6 months
- patients treated for a renal indication during the last 6 months with a course of systemic immunosuppressive agents or intensification of treatment with systemic 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.
- Pregnancy or breastfeeding
- Presence of other transplanted organ besides a kidney transplant
- Severe lactose intolerance
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with tolvaptan
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
1750 Patients enrolled
Trial Details
Trial ID
NCT05374291
Start Date
November 8 2022
End Date
July 1 2027
Last Update
December 4 2025
Active Locations (90)
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1
Canberra Health Services
Canberra, Australian Capital Teritory, Australia
2
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
3
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
4
Liverpool Hospital
Sydney, New South Wales, Australia