Status:
COMPLETED
The POWERED Study: Prophylaxis With Metformin to Prevent PTDM
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Post-transplant Diabetes Mellitus
New Onset Diabetes After Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney disease. However, up to 30% of new renal transplants develop post-transplant diabetes mellitus (PTDM). The de...
Eligibility Criteria
Inclusion
- Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department
- Aged 18-75 inclusively
- Willing to comply with study schedule
Exclusion
- History of Type 1 or type 2 diabetes
- Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
- Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- Subject with a known hypersensitivity or contraindication to Tacrolimus
- Subject with a known hypersensitivity or contraindication to Metformin
- Pregnant or breast feeding
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05240274
Start Date
January 25 2019
End Date
August 30 2022
Last Update
October 18 2022
Active Locations (1)
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1
Royal London Hospital, Barts Health NHS Trust
London, United Kingdom, E1 1BB