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NCT02910531 · ClinicalTrials.gov registry record · Phase 2
Lipoic Acid Supplement for Cystine Stone
A Phase 2 study of Cystinuria, sponsored by Thomas Chi, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02910531: Active Phase 2 study of Cystinuria, sponsored by Thomas Chi, MD.
NCT02910531 is a Phase 2 study of Cystinuria that is active but no longer recruiting, run by Thomas Chi, MD. The registered enrollment target is 50 participants, below the 888-participant average among 4 other Cystinuria trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02910531, a Phase 2 study of Cystinuria, is active but no longer recruiting, sponsored by Thomas Chi, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. The funding source for this clinical trial is FDA OOPD.
Primary Outcome
The primary efficacy endpoint will be assessed in two ways: 1. symptomatic stone recurrences, defined as renal colic, stone passage, or surgical removal of a stone; 2. silent stone recurrences, classified as stone growth or new stones, diagnosed on the basis of renal ultrasound, plain KUB x-ray, or if clinically indicated, computed tomography.
Conditions Studied
Interventions
- DRUG Placebo
- DIETARY_SUPPLEMENT Alpha lipoic acid
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2025-06 |
| Phase | Phase 2 |
What the registry record for NCT02910531 still lists
NCT02910531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 888-participant average among 4 other Cystinuria trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Cystinuria appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02910531 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02910531 about?
NCT02910531 is a clinical study titled "Lipoic Acid Supplement for Cystine Stone". This study evaluates how daily alpha lipoic acid supplementation affects cystine kidney stone recurrence. Half of the subjects will receive 1200 mg alpha lipoic acid orally daily for three years, while the other half will receive a placebo. The funding source for this clinical trial is FDA OOPD.
What is the current status of trial NCT02910531?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-06-19. Estimated completion is 2025-06.
What conditions does trial NCT02910531 study?
This clinical trial studies the following conditions: Cystinuria.
What interventions are being tested in trial NCT02910531?
The interventions under investigation include: Placebo (DRUG), Alpha lipoic acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02910531?
This trial is sponsored by Thomas Chi, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02910531 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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