The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 16, 2009
January 1, 2009
1 year
April 18, 2006
January 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint: The change in serum phosphorus after 8 weeks of niacinamide versus placebo.
Secondary Outcomes (1)
Secondary endpoints: To assess the effects of niacinamide on calcium-phosphorus product, biointact parathyroid hormone levels (biPTH), and lipid profiles after 8 weeks of therapy.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University Medical Center
St Louis, Missouri, 63110, United States
Related Publications (2)
Cheng SC, Young DO, Huang Y, Delmez JA, Coyne DW. A randomized, double-blind, placebo-controlled trial of niacinamide for reduction of phosphorus in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Jul;3(4):1131-8. doi: 10.2215/CJN.04211007. Epub 2008 Apr 2.
PMID: 18385391RESULTNatale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel W Coyne, M.D>
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 18, 2006
First Posted
April 20, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2007
Study Completion
December 1, 2007
Last Updated
January 16, 2009
Record last verified: 2009-01