Feasibility Study of Metformin Therapy in ADPKD



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:30 - 60
Updated:10/14/2018
Start Date:November 2016
End Date:June 2020
Contact:Beverly Farmer, RN,BSN, CCRC
Email:Beverly.Farmer@ucdenver.edu
Phone:303-724-7790

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Godela Brosnahan, MD
?
mi
from
Aurora, CO
Click here to add this to my saved trials