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

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Niacinamide
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia, End Stage Renal Disease, Renal Osteodystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Washington University Medical Center

Outcomes

Primary Outcome Measures

Primary Endpoint: The change in serum phosphorus after 8 weeks of niacinamide versus placebo.

Secondary Outcome Measures

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.

Full Information

First Posted
April 18, 2006
Last Updated
January 14, 2009
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00316472
Brief Title
The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
Official Title
The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
Hyperphosphatemia, End Stage Renal Disease, Renal Osteodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Niacinamide
Primary Outcome Measure Information:
Title
Primary Endpoint: The change in serum phosphorus after 8 weeks of niacinamide versus placebo.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Coyne, M.D>
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18385391
Citation
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.
Results Reference
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The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients

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