Status:
COMPLETED
Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
BioMarin Pharmaceutical
Conditions:
Kidney Disease
Albuminuria
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of developing cardiovascular disease (CVD) which is often associated with hypertension, left ventricular hypertrophy, e...
Detailed Description
ABSTRACT Background: Chronic kidney disease (CKD) is characterized by a high propensity to cardiovascular disease (CVD); therefore treatments that impact both CKD and CVD are needed. CKD is accompanie...
Eligibility Criteria
Inclusion
- Patients with controlled hypertension (blood pressure (BP) less than 150/90 mmHg) using standard antihypertensive medications.
- Stable chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) 40-90 ml/min/173m2 by the abbreviated Modification of Diet in Renal Disease (MDRD) equation and with a rate of decline of eGFR no greater than 1ml/min/1.73m2 per month over the prior 3 months with albuminuria (urine albumin excretion in the 24-hr urine sample of between 300-3000mg).
- No concomitant use with:
- Vitamin C supplements
- Multivitamins containing vitamin C
- Any other dietary supplements, nutraceuticals, or other over-the- counter products containing vitamin C
- Vitamin E containing supplements
- Concurrently taking study approved antihypertensive medications at a stable dose for at least 3 months prior to screening.
- Sexually active subjects must be willing and able to use an acceptable method of contraception
- Females of childbearing potential must have a negative pregnancy test at screening. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy.
Exclusion
- Uncontrolled hypertension with BP greater than 150/90 or with frequent changes to antihypertensive regimen during the last 3 months.
- Concurrent disease or condition that would interfere with study participation or safety, such as bleeding disorders, history of syncope or vertigo; severe gastroesophageal reflux disease (GERD) or gastric ulcers; heart failure; symptomatic coronary or peripheral vascular disease; arrhythmia; serious neurologic disorders, including seizures; or organ transplant.
- Diabetics that are uncontrolled, unstable, newly diagnosed, or have undergone major changes in therapy in the last three months or HbA1C consistently greater than 9.0.
- Any severe comorbid condition that would limit life expectancy to less than 6 months.
- Advanced stage III CKD or worse , i.e. eGFR less than 40 ml/min/1.73m2 (by abbreviated MDRD formula).
- History of nephrolithiasis.
- Patients with albuminuria due to causes other than hypertension and /or diabetes; e.g., systemic lupus erythematosus (SLE).
- Hepatic enzyme concentrations greater than 2 times the upper limit of normal.
- HIV infection, hepatic cirrhosis, other preexisting liver disease, or positive HIV, Hepatitis B or C test at screening.
- Concomitant treatment with drugs known to inhibit folate metabolism, Levodopa, phosphodiesterase (PDE) 5 inhibitors or PDE 3 inhibitors.
- Myocardial infarction, stroke, or surgery within the last 60 days prior to screening.
- History of alcohol and/or drug abuse.
- Pregnant or breastfeeding at screening, or planning to become pregnant (subject or partner) at any time during the study.
- Previous treatment with tetrahydrobiopterin (6R-BH4).
- Has known hypersensitivity to 6R-BH4 or its excipients.
- Any condition that, in the view of the principal investigator (PI), places the subject at high risk of poor treatment compliance or of not completing the study.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00625820
Start Date
May 1 2008
End Date
September 1 2008
Last Update
October 18 2016
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109