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NCT02038543 · ClinicalTrials.gov registry record · Phase 1
Hydroxyproline Influence on Oxalate Metabolism
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02038543: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02038543 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02038543, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Primary hyperoxaluria is an inborn error of metabolism that results in marked overproduction of oxalate by the liver. The excess oxalate causes kidney failure and can cause severe systemic disease due to oxalate deposition in multiple body tissues. Metabolic pathways that lead to oxalate are poorly understood, but recent evidence suggests that hydroxyproline may play a role. Sources of hydroxyproline include the diet and bone turnover. If hydroxyproline can be confirmed as a significant factor in primary hyperoxaluria, diet modification might be of value in reducing the severity of disease. This protocol, in which hydroxyproline labelled with a cold isotope is infused intravenously in patients with primary hyperoxaluria, will allow the researchers to measure the amount of oxalate produced from hydroxyproline. The contribution of hydroxyproline metabolism to the amount of oxalate excreted in urine in will be able to be determined for patients with each of the known types of primary hyperoxaluria.
Primary Outcome
The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled \[15N,13C5\]-Hyp that is circulating in the plasma.
Interventions
- DRUG Hydroxyproline and Leucine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT02038543 record still lists
NCT02038543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydroxyproline and Leucine is the first listed.
NCT02038543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02038543 about?
NCT02038543 is a clinical study titled "Hydroxyproline Influence on Oxalate Metabolism". Primary hyperoxaluria is an inborn error of metabolism that results in marked overproduction of oxalate by the liver. The excess oxalate causes kidney failure and can cause severe systemic disease due to oxalate deposition in multiple body tissues. Metabolic pathways that lead to oxalate are poorly...
What is the current status of trial NCT02038543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-09. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02038543?
The interventions under investigation include: Hydroxyproline and Leucine (DRUG).
Who is sponsoring clinical trial NCT02038543?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02038543's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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