Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

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

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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.

Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control group

Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out.

Group Type ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type DRUG

Calcium Carbonate 500mg per oral, twice a day

nicotinic acids group

Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out.

Group Type EXPERIMENTAL

Nicotinic Acids

Intervention Type DRUG

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.

Interventions

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Nicotinic Acids

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.

Intervention Type DRUG

Calcium Carbonate

Calcium Carbonate 500mg per oral, twice a day

Intervention Type DRUG

Other Intervention Names

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Niacin Calcite

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No