Clinical Trial: Feasibility Study of Metformin Therapy in ADPKD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Colorado, Denver

Current Primary Outcome: 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, and the percentage of participants who are prescribed at least 50% of the randomized dose


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: September 13, 2016
Date Started: November 2016
Date Completion: October 2018
Last Updated: November 4, 2016
Last Verified: November 2016