Feasibility Study of Metformin Therapy in ADPKD
2 other identifiers
interventional
56
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2020
CompletedResults Posted
Study results publicly available
September 5, 2021
CompletedSeptember 5, 2021
August 1, 2021
3.8 years
September 13, 2016
August 10, 2021
August 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in Total Kidney Volume
12 months
Change in Kidney Function
12 months
Rate of Serious Adverse Events (SAE)
12 months
Study Arms (2)
Metformin
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Related Publications (6)
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.
PMID: 21262823BACKGROUNDSatriano 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.
PMID: 23825068BACKGROUNDHung 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. doi: 10.1002/pds.3432.
PMID: 23592561BACKGROUNDSt Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PMID: 39356039DERIVEDEl-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PMID: 38837240DERIVEDBrosnahan GM, Wang W, Gitomer B, Struemph T, George D, You Z, Nowak KL, Klawitter J, Chonchol MB. Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease: A Feasibility Study. Am J Kidney Dis. 2022 Apr;79(4):518-526. doi: 10.1053/j.ajkd.2021.06.026. Epub 2021 Aug 12.
PMID: 34391872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Godela Brosnahan, MD
- Organization
- University of Colorado Denver | Anschutz
Study Officials
- PRINCIPAL INVESTIGATOR
Godela M Brosnahan, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 16, 2016
Study Start
November 1, 2016
Primary Completion
August 17, 2020
Study Completion
August 17, 2020
Last Updated
September 5, 2021
Results First Posted
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share