Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2024-06-15
• Target enrollment: 0
• Participant gender: All

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 pre-existing type. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

1. Male or females >18 years old ≥ 6months after kidney transplantation;

2. Diagnosis of T2D or PTDM;

3. HbA1c of 6.5% to 10%;

4. eGFR ≥30 ml/min/1.73m^2 (as per the CKD-EPI equation);

5. BMI ≤45kg/m^2;

6. Blood pressure ≤160/90 and ≥90/60 at screening.

Exclusion Criteria:

1. Diagnosis of type 1 diabetes;

2. Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain);

3. Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening;

4. Prior episode of graft pyelonephritis in the 1 month prior to screening;

5. Episode of acute graft rejection in the 3 months prior to screening;

6. Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening;

7. Untreated urinary or genital tract infection;

8. Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness;

9. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;

10. Participation in another trial with an investigational drug within 30 days of informed consent;

11. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation;

12. Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement.

13. Patients currently using antipsychotic medications.

14. Use of SGLT2 inhibitors within 1 month of starting the study.