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Feasibility Study of Metformin Therapy in ADPKD

The primary purpose of the research study is to determine the safety and tolerability of the study drug (Metformin or placebo) when given to subjects with ADPKD. Although the exact mechanism of cyst formation in ADPKD is still unclear, it would appear that drugs like Metformin may decrease both cell proliferation and fluid secretion and thus possibly reduce cyst growth. Changes in kidney function and kidney size will be evaluated. Participants will be randomized to receive either Metformin or placebo. The study drug will be taken twice a day for one year. Visits are every 3 months. For patients who are out of state, arrangements will be made to collect quarterly labs in each participant’s home town.

Intervention:

Drug: Metformin
Drug: Placebo

Participation information:

  • Participants will have study visits every 3 months for 1 year.
  • Participants will check daily blood sugars for 2 weeks after the first dose of study drug and then after each dose change.
  • Will have various tests performed including MRI of the abdomen and lab work.

Participation criteria:

Inclusion criteria:

  • Age 30 – 60 years
  • Confirmed diagnosis of ADPKD based on RAvine criteria
  • Estimated glomerular filtration rate greater than or equal to 50 mL/min/1.73 m2 and less than or equal to 80 mL/min/1.73 m2
  • Controlled blood pressure at less than 130/80 mmHG on a stable antihypertensive regimen for at least 4 weeks

Exclusion Criteria:

  • Uncontrolled hypertension
  • Current smokers or history of smoking in the past 12 months
  • Diabetes mellitus
  • Females of childbearing age not willing to use contraception
  • Pregnancy/lactation
  • BMI less than 21 kg/m2

Contact information:

Beverly Farmer, RN, BSN, CCRC
303-724-7790
Beverly.Farmer@ucdenver.edu

Diana George
303-724-1684
Diana.George@ucdenver.edu