The POWERED Study: Prophylaxis With Metformin to Prevent PTDM

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

PrOphylaxis With mEtformin to pREvent PTDM: a single site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of metformin to prevent post-transplant diabetes in a cohort of patients undergoing renal transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department

2. Aged 18-75 inclusively

3. Willing to comply with study schedule

Exclusion Criteria:

1. History of Type 1 or type 2 diabetes

2. Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease

3. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug

4. Subject with a known hypersensitivity or contraindication to Tacrolimus

5. Subject with a known hypersensitivity or contraindication to Metformin

6. Pregnant or breast feeding