Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Study Overview
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Brief Summary
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With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia

Detailed Description
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Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.

Official Title
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The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: Nicotinic Acids
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ethnic Han live in China, End-stage renal disease（ESRD）patients treated with hemodialysis ≥ 3 months, between 18 and 80 years of age, serum phosphorus > 1.78 mmol/L, capable of giving informed consent Exclusion Criteria: Be allergic to nicotinic acids, dysphagia, pregnant, current medication regimen including niacin or niacinamide active liver disease, peptic ulcer disease, full resection of parathyroid, malignancy, quit hemodialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out. | Drug: Calcium Carbonate<br>* Calcium Carbonate 500mg per oral, twice a day<br>* Other names: Calcite;|
| Experimental: nicotinic acids group<br>Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out. | Drug: Nicotinic Acids<br>* Nicotinic acids is administered at an initial dosage of 50mg four times daily in the first week. If no significant side effects detected, the dosage will be titrated to 100mg five times daily within the second week and last to the end of study.<br>* Other names: Niacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum phosphorus |  | Immediately after wash-out period and after 6 weeks of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum calcium |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in serum calcium-phosphorus product |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in intact parathyroid hormone |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in alkaline phosphatase |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in platelet count |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in serum uric acid |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in serum glucose |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in total cholesterol |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in triglyceride |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in high density lipoprotein cholesterol |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in low density lipoprotein cholesterol |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in serum glutamic-pyruvic transaminase |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in glutamic oxalacetic transaminase |  | Immediately after wash-out period and after 6 weeks of therapy. | 
| change in bilirubin |  | Immediately after wash-out period and after 6 weeks of therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis,Hyperphosphatemia,Nicotinic Acids