Feasibility Study of Metformin Therapy in ADPKD

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-08-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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Polycystic Kidney, Autosomal Dominant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Monitoring of safety and tolerability

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Monitoring of safety and tolerability

Interventions

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Metformin

Monitoring of safety and tolerability

Intervention Type DRUG

Placebo

Monitoring of safety and tolerability

Intervention Type DRUG

Other Intervention Names

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Glucophage Fortamet Glumetza

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No