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NCT Number: NCT02903511

Feasibility Study of Metformin Therapy in ADPKD

This study is being done to determine if treatment with metformin, a drug widely used for the treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly decreased kidney function. The study will also evaluate the effects of metformin on kidney growth and kidney function.

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Key information

About this study

Patients with ADPKD are still in need for a well-tolerated treatment that can be used long-term to prevent cyst growth and kidney function decline. Metformin has a long track record of a low risk-to-benefit profile in patients with diabetes or at risk for diabetes. Metformin inhibits two key processes responsible for the growth of polycystic kidneys, i.e. fluid secretion and cell proliferation, as shown in cell cultures and animal models of ADPKD. Experiments in animal models of chronic kidney disease demonstrate that metformin administration prevents kidney fibrosis and preserves kidney function. Diabetic patients who are treated with metformin appear to develop less kidney failure and live longer than patients who are treated with other anti-diabetic medications. Therefore this drug is promising for people with ADPKD, with the potential to slow cyst enlargement and preserve kidney function.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Autosomal Dominant Polycystic Kidney Disease and
  • An estimated glomerular filtration (GFR) rate of 50-80 ml/min/1.73 m2;
  • Subject is able to sign an Informed Consent

Exclusion criteria

  • Diabetes mellitus,
  • Active infection,
  • Congestive heart failure,
  • Liver disease,
  • Alcohol or substance dependence,
  • Cigarette smoking within the last 12 months;
  • Females who are pregnant or breast feeding, or
  • Are unwilling to use contraception;
  • Are unable to undergo magnetic resonance imaging, or
  • Have a contraindication to the use of metformin

Treatment and study plan

metformin

Drug

Monitoring of safety and tolerability

Other names: Glucophage, Fortamet, Glumetza

Placebo

Drug

Monitoring of safety and tolerability

Primary outcomes

  1. Safety and Tolerability of Metformin

    Time frame: 12 months

    Percentage of participants who at the end of 12 months are still prescribed the full randomized dose of metformin or placebo, and the percentage of participants who are prescribed at least 50% of the randomized dose

Secondary outcomes

  1. Change in Total Kidney Volume

    Time frame: 12 months

    Total kidney volume will be measured by MRI (magnetic resonance imaging) at baseline and at 12 months. Percentage change from baseline in height-adjusted total kidney volume is reported.

  2. Change in Kidney Function

    Time frame: 12 months

    Estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine measurements at baseline and after 3, 6, 9 and 12 months. Change from baseline at 12 months is reported.

  3. Rate of Serious Adverse Events (SAE)

    Time frame: 12 months

    Serious adverse events occurring from the time of signing informed consent until the end of the study will be monitored in both treatment arms

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2016
Registry last updated
Sep 5, 2021

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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