Phase 2
N=51
Feasibility Study of Metformin Therapy in ADPKD
Polycystic Kidney, Autosomal Dominant
Bottom Line
View on ClinicalTrials.gov: NCT02903511 ↗Enrolled (actual)
51
Serious AEs
3.9%
Results posted
Sep 2021
Primary outcome: Primary: Safety and Tolerability of Metformin — 50; 100; 82; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Metformin |
50; 100; 82; 100 | — |
| SECONDARY Change in Total Kidney Volume |
3.45; 3.15 | — |
| SECONDARY Change in Kidney Function |
-0.41; -3.35 | — |
| SECONDARY Rate of Serious Adverse Events (SAE) |
2; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02903511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.