| Trial ID: | L6637 |
| Source ID: | NCT02903511
|
| Associated Drug: |
Metformin
|
| Title: |
Feasibility Study of Metformin Therapy in ADPKD
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02903511/results
|
| Conditions: |
Polycystic Kidney, Autosomal Dominant
|
| Interventions: |
DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
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|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|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
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-11
|
| Completion Date: |
2020-08-17
|
| Results First Posted: |
2021-09-05
|
| Last Update Posted: |
2021-09-05
|
| Locations: |
University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02903511
|
