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Feasibility Study of Metformin Therapy in ADPKD

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ClinicalTrials.gov Identifier: NCT02903511
Recruitment Status : Active, not recruiting
First Posted : September 16, 2016
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Polycystic Kidney, Autosomal Dominant Drug: Metformin Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.
Study Start Date : November 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Metformin
Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.
Drug: Metformin
Monitoring of safety and tolerability
Other Names:
  • Glucophage
  • Fortamet
  • Glumetza

Placebo Comparator: Placebo
Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.
Drug: Placebo
Monitoring of safety and tolerability




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


Secondary Outcome Measures :
  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

  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

  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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903511


Locations
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United States, Colorado
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Godela M Brosnahan, MD University of Colorado, Denver

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02903511     History of Changes
Other Study ID Numbers: 16-0802
R21DK107969-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Metformin
total kidney volume
glomerular filtration rate
Additional relevant MeSH terms:
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Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs