NCT02836184

Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Jiujiang No.1 People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
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.
DRUG	Calcium Carbonate	Calcium Carbonate 500mg per oral, twice a day

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-07-18
• Last updated: 2016-08-30

Locations

1 site across 1 country: China