Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia (NAHPH)

Jiujiang No.1 People's Hospital

Status and phase: Unknown; Phase 4

Conditions: Hyperphosphatemia

Treatments: Drug: Nicotinic Acids; Drug: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02836184

2016075

Details and patient eligibility

About

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

Full description

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

control group

Active Comparator group

Description:

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

Treatment:

Drug: Calcium Carbonate

nicotinic acids group

Experimental group

Description:

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

Treatment:

Drug: Nicotinic Acids