The POWERED Study: Prophylaxis With Metformin to Prevent PTDM

NCT05240274 | Completed Phase 2 DMC

• 1 other identifier: 203080
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 cohort of patients undergoing renal transplantation.

Conditions

Post-transplant Diabetes Mellitus; New Onset Diabetes After Transplant; New Onset Diabetes After Transplantation; Kidney Transplant; Complications; Renal Transplantation; End Stage Renal Disease; Metformin

Keywords

post-transplant diabetes mellitus; new onset diabetes after transplant; renal transplant; kidney transplant; end-stage kidney disease; metformin; PTDM; NODAT

Outcome Measures

Primary Outcomes (1)

• Diagnosis of post-transplant diabetes

  Positive 2 hour oral glucose tolerance test (i.e. 2 hour sugar \>11.1 mol/L)

  12 months post-renal transplant

Secondary Outcomes (8)

• Pancreatic beta cell function

  12 months

• HbA1c

  12 months

• impaired glucose tolerance

  12 months

• patient and graft survival

  12 months

• incidence of treatment emergent adverse events

  12 months

Study Arms (2)

Metformin

ACTIVE COMPARATOR

metformin 500mg OD

Drug: Metformin

Placebo

PLACEBO COMPARATOR

placebo 500mg OD

Drug: Placebo

Interventions

Metformin DRUG

metformin 500mg OD for 3 months to start within 10 days post-renal transplant

Metformin

Placebo DRUG

placebo 500mg OD for 3 months to start within 10 days post-renal transplant

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Royal London Hospital, Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kieran McCafferty, M.B., B.Chir

  Barts Health NHS Trust; Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the patient and the study team will be blinded to the treatment intervention. The clinical team will also be blinded. Pharmacy staff who dispense the IMP will not be blinded, nor will Sponsor Office staff responsible for reporting unblinded SUSAR reports to the MHRA.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, placebo controlled, double blind randomised clinical trial

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 15, 2022
• Study Start: January 25, 2019
• Primary Completion: May 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 18, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. The data may be used for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found by emailing the corresponding author.

Locations

GB (1)