Clinical Trial: Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Jiujiang No.1 People's Hospital

Current Primary Outcome: change in serum phosphorus [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Jiujiang No.1 People's Hospital

Dates:
Date Received: July 14, 2016
Date Started: July 2016
Date Completion: September 2016
Last Updated: August 29, 2016
Last Verified: July 2016