Trial | NCT02836184  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    45
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
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.
Study Started
Jul 31
2016
Primary Completion
Sep 30
2016
Anticipated
Study Completion
Sep 30
2016
Anticipated
Last Update
Aug 30
2016
Estimate

Drug 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.

  • Other names: Niacin

Drug Calcium Carbonate

Calcium Carbonate 500mg per oral, twice a day

  • Other names: Calcite

control group Active Comparator

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

nicotinic acids group Experimental

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

Criteria 

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
No Results Posted