Polycystic Kidney, Autosomal Dominant Clinical Trial
Official title:
Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.
Verified date | August 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | August 17, 2020 |
Est. primary completion date | August 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver, Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Hung AM, Roumie CL, Greevy RA, Liu X, Grijalva CG, Murff HJ, Griffin MR. Kidney function decline in metformin versus sulfonylurea initiators: assessment of time-dependent contribution of weight, blood pressure, and glycemic control. Pharmacoepidemiol Drug Saf. 2013 Jun;22(6):623-31. — View Citation
Satriano J, Sharma K, Blantz RC, Deng A. Induction of AMPK activity corrects early pathophysiological alterations in the subtotal nephrectomy model of chronic kidney disease. Am J Physiol Renal Physiol. 2013 Sep 1;305(5):F727-33. doi: 10.1152/ajprenal.00293.2013. Epub 2013 Jul 3. — View Citation
Takiar V, Nishio S, Seo-Mayer P, King JD Jr, Li H, Zhang L, Karihaloo A, Hallows KR, Somlo S, Caplan MJ. Activating AMP-activated protein kinase (AMPK) slows renal cystogenesis. Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2462-7. doi: 10.1073/pnas.1011498108. Epub 2011 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability of Metformin | Percentage of participants who at the end of 12 months are still prescribed the full randomized dose of metformin or placebo, and the percentage of participants who are prescribed at least 50% of the randomized dose | 12 months | |
Secondary | Change in Total Kidney Volume | Total kidney volume will be measured by MRI (magnetic resonance imaging) at baseline and at 12 months. Percentage change from baseline in height-adjusted total kidney volume is reported. | 12 months | |
Secondary | Change in Kidney Function | Estimated glomerular filtration rate (eGFR) will be calculated from serum creatinine measurements at baseline and after 3, 6, 9 and 12 months. Change from baseline at 12 months is reported. | 12 months | |
Secondary | Rate of Serious Adverse Events (SAE) | Serious adverse events occurring from the time of signing informed consent until the end of the study will be monitored in both treatment arms | 12 months |
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