Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01356966
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01356966
Study Brief:
Protocol Section:
NCT01356966