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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
EU CTIS ID: 2023-508389-13-00
What this study is testing
To determine whether dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of kidney failure, hospitalization for heart failure, and all-cause mortality in the overall patient group, consisting of patients with eGFR ≤25 mL/min/1.73m2, dialysis patients, and kidney transplant recipients with eGFR ≤45 mL/min/1.73m2.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (at least 3 months after start of dialysis); transplant patients with an eGFR ≤45 mL/min/1.73m2 (at least 6 months after transplantation)
- 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.
You likely can't join if
- Mentally incapacitated subjects (i.e. not able to sign informed consent)
- 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 (of note: The study medication contains so little lactose that most people with lactose intolerance do not suffer from this.)
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with tolvaptan
See the full eligibility 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 (at least 3 months after start of dialysis); transplant patients with an eGFR ≤45 mL/min/1.73m2 (at least 6 months after transplantation)
- 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.
- Mentally incapacitated subjects (i.e. not able to sign informed consent)
- 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 (of note: The study medication contains so little lactose that most people with lactose intolerance do not suffer from this.)
- Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with tolvaptan
- 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
- 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. Of note, this implies that patients receiving non-systemic immunosuppression (e.g. topical, ophthalmic, rectal, intra-articular or inhaled corticosteroids) are allowed to participate, as well as patients having received a short course of oral/IV steroids within 6 months prior to screening for non-renal indications (e.g. for gout or an asthma flare) as well as patients receiving during the last 6 months stable low-dose immunosuppression for whatever reason (e.g. kidney transplant recipients, patients with GPA, patients with gout).
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.