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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dapagliflozin, which belongs to a group of drugs known as SGLT2 inhibitors. The goal is to see if this medication can help lower blood pressure in kidney transplant recipients, including those who have type 2 diabetes or post-transplant diabetes. The trial will include 52 participants who are at least 18 years old and have been through kidney transplantation for at least six months. To be eligible, participants should have specific blood sugar levels and kidney function, as well as certain blood pressure ranges.

Participants in this study will be randomly assigned to receive either dapagliflozin or a placebo (a dummy pill with no active medication) for comparison. Throughout the trial, researchers will closely monitor their health to ensure safety and assess the effectiveness of the treatment. It’s important to note that individuals with certain health conditions, like type 1 diabetes or severe heart problems, will not be able to participate. This study aims to provide valuable information that could help improve the health care of kidney transplant recipients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or females \>18 years old ≥ 6months after kidney transplantation;
• • 2. In patients with T2D or PTDM, HbA1c \<12.0%;
• • 3. eGFR ≥30 ml/min/1.73m\^2 (as per the CKD-EPI equation);
• • 4. BMI ≤45kg/m\^2;
• • 5. 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.