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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
NCT02903511 |
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Date of registration:
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13/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Feasibility Study of Metformin Therapy in ADPKD
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Scientific title:
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Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease. |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02903511 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Godela M Brosnahan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Polycystic Kidney, Autosomal Dominant
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Intervention(s)
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Drug: Metformin
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Drug: Placebo
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Primary Outcome(s)
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Safety and tolerability of metformin
[Time Frame: 12 months]
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Secondary Outcome(s)
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Change in kidney function
[Time Frame: 12 months]
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Change in total kidney volume
[Time Frame: 12 months]
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Rate of Serious Adverse Events (SAE)
[Time Frame: 12 months]
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Secondary ID(s)
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R21DK107969-01A1
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16-0802
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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