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NCT03663855 · ClinicalTrials.gov registry record · Phase 2
Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03663855: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT03663855 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663855, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility in the urine, in patients with cystinuria to evaluate the effect of escalating doses of cystine binding thiol drugs on the cystine capacity of the urine. The overall goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by larger dosages. Cystinuria is a rare genetic disease that can lead to significant morbidity in affected patients due to the recurrent nature of the disease. This study will follow the levels of urine cystine capacity in order to help guide treatment and to use lower than usually prescribed Tiopronin doses to decrease the potential side effects while maintaining therapeutic benefit. This will increase adherence with the medications by decreasing the burden of the large number of pills that need to be taken daily.
Primary Outcome
This measure reflects the ability of urine to take up more cystine
Interventions
- DRUG Tiopronin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 2 |
What the finished NCT03663855 record still lists
NCT03663855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Tiopronin is the first listed.
NCT03663855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03663855 about?
NCT03663855 is a clinical study titled "Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria". The purpose of this study is to determine the minimum effective dose of the cysteine binding thiol drug (CBTD) Tiopronin on urine cystine capacity, which is a measure of cystine solubility in the urine, in patients with cystinuria to evaluate the effect of escalating doses of cystine binding thiol d...
What is the current status of trial NCT03663855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-11-01. Estimated completion is 2019-09-10.
What interventions are being tested in trial NCT03663855?
The interventions under investigation include: Tiopronin (DRUG).
Who is sponsoring clinical trial NCT03663855?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03663855's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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