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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01356966
The ClinicalTrials.gov registry entry for NCT01356966 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 329-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (78% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.