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Exercise Intolerance in Renal Failure
NCT01356966 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01356966 reports 2 study locations spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01356966?
The interventions under investigation include: Placebo (DRUG), Tetrahydrobiopterin (DRUG), Folate (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01356966?
This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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