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Exercise Intolerance in Renal Failure

NCT01356966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-06-01

Study results available
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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

  • Kidney Failure, Chronic

Interventions

DRUG

Tetrahydrobiopterin

Tetrahydrobiopterin (BH4) 200 mg PO BID for 12 weeks

DRUG

Placebo

2 placebo pills PO BID for12 weeks

DIETARY_SUPPLEMENT

Folate

Folate 1 mg daily for 12 weeks

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Jeanie Park, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356966 on ClinicalTrials.gov