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Completed

NCT Number: NCT05240274

The POWERED Study: Prophylaxis With Metformin to Prevent PTDM

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.

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Key information

Conditions

Post-transplant Diabetes Mellitus Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Kidney Transplant; Complications Male Urogenital Diseases Metformin New Onset Diabetes After Transplant New Onset Diabetes After Transplantation Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Transplantation Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal London Hospital, Barts Health NHS Trust

London, E1 1BB, United Kingdom

About this study

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 development of PTDM is associated with adverse graft and patient survival outcomes and represents an increased financial burden. There is an urgent clinical need to discover therapies which could decrease the risk of developing PTDM. Metformin offers a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to study its safety and efficacy in preventing the development of PTDM.

POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of metformin in patients without pre-existing diabetes mellitus who have received a new renal transplant. Eligible, consented patients are randomised to a 3 month course of either active drug or placebo within 10 days post-transplant. All patients will receive the usual standard of care for transplant patients. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. The primary endpoint is the development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study began recruitment in January 2019 and plans to enrol 60 patients. There are no interim analyses planned.

Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC 18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor in accordance with local data protection law. Results of the trial will be submitted for publication in a peer-reviewed journal.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

metformin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Diagnosis of post-transplant diabetes

    Time frame: 12 months post-renal transplant

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

Secondary outcomes

  1. Pancreatic beta cell function

    Time frame: 12 months

    change in calculated HOMA-IR using C-peptide measurement between baseline and month 3 using

  2. HbA1c

    Time frame: 12 months

    HbA1c

  3. impaired glucose tolerance

    Time frame: 12 months

    impaired glucose tolerance as per 2 hour oral glucose tolerance test (i.e. 2 hour glucose 7.9-11.1 mmol/L)

  4. patient and graft survival

    Time frame: 12 months

    patient survival, kidney transplant (graft) survival

  5. incidence of treatment emergent adverse events

    Time frame: 12 months

    patient safety: adverse events, serious adverse events

  6. rejection

    Time frame: 12 months

    episodes of acute transplant rejection

  7. eGFR

    Time frame: 12 months

    renal transplant function

  8. diagnosis of PTDM in OGTT screen fails

    Time frame: 12 months

    incidence of PTDM in patients not randomised to study due to positive OGTT at screening: defined by appearance of PTDM on problem list or prescription of an anti-diabetic drug

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Acronym: POWERED

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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