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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00316472 |
Elevated phosphorus levels are a common problem in dialysis patients. However, it is associated with an increase in death and hospitalizations. Current treatment is comprised of dietary modifications and phosphorus binders - though this is often not enough for many of our patients. Our trial investigates the use of niacinamide, a form of vitamin B, in decreasing serum phosphorus levels.
Condition | Intervention | Phase |
---|---|---|
Hyperphosphatemia |
Drug: Niacinamide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients |
Estimated Enrollment: | 40 |
Study Start Date: | April 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
This is a prospective, randomized, double-blind, placebo-controlled crossover study comparing niacinamide versus placebo in the reduction of serum phosphorus in hemodialysis patients. A determination of baseline laboratory values (serum phosphorus, calcium, albumin, biPTH, uric acid, complete blood count (CBC), and an NMR lipid panel) will precede the administration of the study drugs. The study will span a period of 21 weeks during which phosphorus levels will be checked on a weekly basis. Phosphorus binder dose will remain unchanged unless for safety reasons. For the first 8 weeks of treatment, patients will be randomized to either placebo or niacinamide. Both medications will be administered with a starting dose of one capsule twice per day (BID). Niacinamide and placebo will be formulated in 250 mg capsules. Placebo will be packaged to resemble the study drug in all physical attributes. The dose of niacinamide or placebo will be increased to 500 mg (2 capsules) BID at week 3 and 750 mg (3 capsules) BID at week 5. If hypophosphatemia (< 3.5 mg/dl) is present, then titration will not occur and the previous dose will be continued. However, titration will resume in subsequent weeks if the serum phosphorus is greater than 3.5 mg/dl. After 8 weeks, patients will undergo a 2 week washout period, then crossover from treatment arm to placebo, or vice versa, at week 11.
At the beginning of week 11, patients will cross over to the other treatment arm (either placebo or niacinamide) at one capsule (250 mg) twice per day. Subsequent titration will occur at week 13 and week 15. The treatment phase will be completed at the end of week 18. A set of labs will be drawn at the start of week 19, followed by a two week washout period.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University Medical Center | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Daniel W Coyne, M.D> | Washington University Medical Center |
Responsible Party: | Washington University ( Daniel Coyne, MD ) |
Study ID Numbers: | HSC05-0958 |
Study First Received: | April 18, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00316472 |
Health Authority: | United States: Institutional Review Board |
Hyperphosphatemia End Stage Renal Disease Renal Osteodystrophy |
Niacinamide Metabolic Diseases Renal Osteodystrophy Renal osteodystrophy |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Metabolic disorder |
Phosphorus Metabolism Disorders Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |