Sponsor study identifier
interventional
17
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients also manifest a decrease in nitric oxide (NO) availability which is thought to play an important role in their progressive vascular disease. Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS), an important regulator of NO and that is a key mediator of endothelial dysfunction. Changes in NO availability are believed to contribute to endothelial dysfunction seen in CKD and common CVD states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an investigational oral drug that is being evaluated to determine whether it will restore NO availability, leading to beneficial effects on vascular function and ultimately positive clinical outcomes in patients with CKD. The primary endpoint in this study is the level of albuminuria, an easily measured marker that has served as a predictor of kidney disease progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have implications to slow the disease progression as well as decreased risk of CVD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2008
Actual (reported)February 28, 2008
Actual (reported)May 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Actual (reported)September 2008
Actual (reported)October 18, 2016
Actual (reported)The Primary Outcome Measure is Level of Albuminuria.
Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.
12 weeks
Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy.
12 weeks
Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy.
12 weeks
Subjects will receive 6R-BH4 400mg bid for 6 weeks, sequentially followed by 6R-BH4 plus Vitamin C 500mg bid for another 6 weeks. Patients will have scheduled visits at Weeks 0,3,6,9 and 12, with an exit-visit at week 16. Albuminuria will be assessed in 24-hour urine collections as well as early morning spot urine samples for albumin:creatinine ratio. Blood and urine will be tested for routine clinical laboratory tests, blood nitric oxide (NO), and also archived for later assays for special biomarkers. The primary outcome will be level of albuminuria as measured in a 24-hour urine collection at 6 and 12 weeks of therapy. Secondary outcomes will include urine albumin/creatinine ratio, estimated glomerular filtration rate (eGFR), and blood pressure .
400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks in all arms
University of Michigan
Ann Arbor, Michigan, 48109, United States
It was a small single center non-randomized pilot study \& was not powered to detect significant changes in albuminuria.
Rajiv Saran, MD
University of Michigan
17 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Exercise Intolerance in Renal Failure
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Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
October 18, 2016
Results First Posted
October 18, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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