Exercise Intolerance in Renal Failure (EIRF)
Kidney Failure, Chronic
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility Criteria
Inclusion Criteria:
chronic kidney disease (CKD) stages I, II, and III and do not regularly exercise
1. CKD Stages I, II, and III will be defined as reduction in estimated glomerular filtration rate (eGFR) to 30-59 cc/minute as calculated by the Modification of Diet in Renal Disease (MDRD) equation, or an eGFR>60 cc/minute with proteinuria greater than 500 mg/g of Creatinine or 500 mg per 24 hours.
- willing and able to cooperate with the protocol
- CKD patients must have stable renal function (no greater than a 20% reduction in eGFR over the prior 3 months)
- controls will be matched for age, gender, race, and hypertensive status.
Exclusion Criteria:
- severe CKD (eGFR<30 cc/minute)
- drug or alcohol abuse
- diabetes
- any serious systemic disease that might influence survival
- severe anemia with hgb level <10 g/dL
- clinical evidence of congestive heart failure or ejection fraction below 35%
- any history of past myocardial infarction or cerebrovascular accident
- symptomatic heart disease determined by electrocardiogram, stress test, and/or history
- treatment with central alpha agonists
- uncontrolled hypertension with BP greater than 160/90 mm Hg
- low blood pressure with BP less than 110/60
- history of nephrolithiasis
- pregnancy or plans to become pregnant
- treatment with vitamin C within the past 3 months
- hepatic enzyme concentrations greater than 2 times the upper limit of normal
- HIV infection
- surgery within the past 3 months
- previous treatment with BH4
- known hypersensitivity to BH4
- any condition that places the participant at high risk of poor adherence or poor follow-up
- patients must be willing to use an acceptable method of contraception if of childbearing age
Sites / Locations
- Emory University Hospital
- Atlanta VA Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tetrahydrobiopterin + Folate
Placebo + Folate
Male subjects with hypertension and chronic kidney disease stage 2 or 3 will receive Tetrahydrobiopterin (6R-BH4) 200 mg twice daily and folic acid 1 mg daily
Male subjects with hypertension and chronic kidney disease stage 2 or 3 will receive 2 placebo pills twice daily and folic acid 1 mg daily