The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients

Completed · Phase 1

Conditions studied: Hyperphosphatemia

In brief

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.

Key facts

Study ID

NCT00316472

Run by

Washington University School of Medicine

People needed

40

Starts

2006-04-01

Expected to finish

2007-12-01

Last updated by the study team

2009-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Capable of giving informed consent
• Duration of chronic hemodialysis > 90 days
• Dose of phosphorus binder(s) stable over previous 2 week period
• Serum Phosphorus > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

You may not qualify if…

• Pregnancy
• Known liver disease
• Active peptic ulcer disease
• Treatment with carbamazepine
• Intolerance to niacinamide
• Current medication regimen including niacin or niacinamide-containing vitamins
• More than 1 missed hemodialysis session in the last 30 days
• Planned or expected surgical procedure in the next 4 months
• Patients in nursing homes or extended care facilities where administration of the study drug may not be appropriately given

Where it is running

• Washington University Medical Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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