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NCT02656017 · ClinicalTrials.gov registry record · Phase 2
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
A Phase 2 study of Polycystic Kidney, Autosomal Dominant, sponsored by Kyongtae Ty Bae, M.D., Ph.D..
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 2
- Study locations
NCT02656017: Completed Phase 2 study of Polycystic Kidney, Autosomal Dominant, sponsored by Kyongtae Ty Bae, M.D., Ph.D..
NCT02656017 is a Phase 2 study of Polycystic Kidney, Autosomal Dominant that has completed, run by Kyongtae Ty Bae, M.D., Ph.D.. The registered enrollment target is 97 participants, above the 53-participant average among 4 other Polycystic Kidney, Autosomal Dominant trials with a reported enrollment target (83% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02656017, a Phase 2 study of Polycystic Kidney, Autosomal Dominant, has completed, sponsored by Kyongtae Ty Bae, M.D., Ph.D..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kidney size and the kidney function, along with its effect on kidney pain and quality of life.
Primary Outcome
GSRS is a widely used, validated 15-item questionnaire used to assess GI symptom burden (minimum, maximum: 1, 7, where higher mean score is worse outcome). Mean change to 24 months, estimated with a repeated measures analysis (baseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 months) using a linear mixed model.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Metformin
Study Locations (2)
Maryland
- University of Maryland Medical Center - Baltimore
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2016-06-27 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 2 |
What the finished NCT02656017 record still lists
NCT02656017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 53-participant average among 4 other Polycystic Kidney, Autosomal Dominant trials with a reported enrollment target (83% higher).
The record links to 1 condition, with Polycystic Kidney, Autosomal Dominant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02656017 reports a single indexed study location in Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02656017 about?
NCT02656017 is a clinical study titled "Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease". This study will test to see if metformin is safe and if it is tolerated compared to placebo in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages of chronic kidney disease. We will also measure its effect on progression of kidney disease as reflected in the kid...
What is the current status of trial NCT02656017?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2016-06-27. Estimated completion is 2020-12-07.
What conditions does trial NCT02656017 study?
This clinical trial studies the following conditions: Polycystic Kidney, Autosomal Dominant.
What interventions are being tested in trial NCT02656017?
The interventions under investigation include: Placebo (OTHER), Metformin (DRUG).
Who is sponsoring clinical trial NCT02656017?
This trial is sponsored by Kyongtae Ty Bae, M.D., Ph.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02656017 being conducted?
This trial has 2 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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