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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00316472

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia	Drug: Niacinamide	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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