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

niversity Medical Center Groningen0 个研究点目标入组 1,500 人开始时间: 2022年3月16日最近更新: 2024年4月15日

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•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
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•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
•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 immunosuppresive agents or intensification of treatment with immunosupressive agents, such as patients with a kidney transplant and acute rejection or patients with GPA (orbus 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 measurements7 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

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