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 range19 Years

SexALL

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);
✕. Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening;
✕. Prior episode of graft pyelonephritis in the 1 month prior to screening;
✕. Episode of acute graft rejection in the 3 months prior to screening;
✕. Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening;
✕. Untreated urinary or genital tract infection;
✕. Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness;

What they're measuring

Systolic blood pressure

Timeframe: Change from baseline systolic blood pressure (SBP) at 12 weeks of treatment

Trial details

NCT IDNCT04965935

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Kidney Transplant Recipients trials