Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients (NCT04965935) | Clinical Trial Compass
CompletedPhase 3
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients
Canada52 participantsStarted 2021-07-15
Plain-language summary
This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM). The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or females \>18 years old ≥ 6months after kidney transplantation;
. In patients with T2D or PTDM, HbA1c \<12.0%;
. eGFR ≥30 ml/min/1.73m\^2 (as per the CKD-EPI equation);
. BMI ≤45kg/m\^2;
. Blood pressure ≤160/90 and ≥90/60 at screening.
Exclusion criteria
. Diagnosis of type 1 diabetes;
. Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at SGLT2 inhibitors specifically in kidney transplant recipients with diabetes — given my own transplant history and diabetes status, is this class of medication something worth discussing for my care?
2Since this was a Phase 3 trial, what does my doctor know about the safety profile of SGLT2 inhibitors in transplant patients, especially around risks like infections or effects on the transplanted kidney?
3The trial measured systolic blood pressure as its main outcome — does my doctor think managing my blood pressure this way could be relevant to protecting my transplanted kidney long-term?
4Now that this trial is completed, has my doctor seen any published results or data from it that might inform whether an SGLT2 inhibitor could be appropriate in my situation?
5Are there standard treatments already approved for post-transplant diabetes or blood pressure management that my doctor would recommend I consider before or alongside any approach studied in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Systolic Blood Pressure (SBP)
Timeframe: Change from baseline SBP at 12 weeks of treatment