A Phase 1/2 interventional study of Niacinamide and Placebo in Hyperphosphatemia, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-30.
Sponsored by Washington University School of Medicine · Phase 1/2, Interventional, and Treatment
Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.
This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels > 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.
152 studies on the registry are indexed under Hyperphosphatemia; 11 are open to participants now.
This study's enrollment of 17 is below the median of 105 across 127 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
Drug: Niacinamide
Placebo
Drug: Placebo
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
Placebo
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
Time frame: 8 weeks
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
Time frame: 8 weeks
The record gives a start of Oct 2006 and a completion of Jul 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niacinamide
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