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NCT01356966 · ClinicalTrials.gov registry record · Phase 2
Exercise Intolerance in Renal Failure
A Phase 2 study of Kidney Failure, Chronic, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT01356966: Completed Phase 2 study of Kidney Failure, Chronic, sponsored by Emory University.
NCT01356966 is a Phase 2 study of Kidney Failure, Chronic that has completed, run by Emory University. The registered enrollment target is 74 participants, below the 329-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356966, a Phase 2 study of Kidney Failure, Chronic, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. The investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certainly contribute to exercise dysfunction as well as cardiovascular risk. The investigators will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney disease. The investigators will test whether short-term treatment with tetrahydrobiopterin (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tetrahydrobiopterin
- DIETARY_SUPPLEMENT Folate
Study Locations (2)
Georgia
- Emory University Hospital - Atlanta
- Atlanta VA Medical Center - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01356966 record still lists
NCT01356966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 329-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01356966 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01356966 about?
NCT01356966 is a clinical study titled "Exercise Intolerance in Renal Failure". Patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. The investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certa...
What is the current status of trial NCT01356966?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2011-05. Estimated completion is 2014-05.
What conditions does trial NCT01356966 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic.
What interventions are being tested in trial NCT01356966?
The interventions under investigation include: Placebo (DRUG), Tetrahydrobiopterin (DRUG), Folate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01356966?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01356966 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Failure, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01356966's enrollment target sits among peer trials
74 10th of 23 higher than 14 of 23 other Kidney Failure, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure, Chronic 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.
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