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NCT00625820 · ClinicalTrials.gov registry record · Phase 2
Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00625820: Completed Phase 2 study, sponsored by University of Michigan.
NCT00625820 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00625820, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of developing cardiovascular disease (CVD) which is often associated with hypertension, left ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients also manifest a decrease in nitric oxide (NO) availability which is thought to play an important role in their progressive vascular disease. Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS), an important regulator of NO and that is a key mediator of endothelial dysfunction. Changes in NO availability are believed to contribute to endothelial dysfunction seen in CKD and common CVD states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an investigational oral drug that is being evaluated to determine whether it will restore NO availability, leading to beneficial effects on vascular function and ultimately positive clinical outcomes in patients with CKD. The primary endpoint in this study is the level of albuminuria, an easily measured marker that has served as a predictor of kidney disease progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have implications to slow the disease progression as well as decreased risk of CVD.
Primary Outcome
Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.
Interventions
- DIETARY_SUPPLEMENT Vitamin C
- DRUG 6R BH4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2008-05 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00625820 record still lists
NCT00625820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Vitamin C is the first listed.
NCT00625820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00625820 about?
NCT00625820 is a clinical study titled "Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria". Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of developing cardiovascular disease (CVD) which is often associated with hypertension, left ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients als...
What is the current status of trial NCT00625820?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2008-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00625820?
The interventions under investigation include: Vitamin C (DIETARY_SUPPLEMENT), 6R BH4 (DRUG).
Who is sponsoring clinical trial NCT00625820?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00625820's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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