Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Overview

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

Full Title of Study: “The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: control group
    • Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out.
  • Experimental: nicotinic acids group
    • Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out.

Clinical Trial Outcome Measures

Primary Measures

  • change in serum phosphorus
    • Time Frame: Immediately after wash-out period and after 6 weeks of therapy.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiujiang No.1 People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaoran Feng, deputy director of nephrology division – Jiujiang No.1 People’s Hospital
  • Overall Official(s)
    • Xiaoran Feng, MD,PHD, Principal Investigator, Department of Nephrology, Jiujiang NO.1 People’s Hospital
  • Overall Contact(s)
    • Xiaoran Feng, MD,PHD, +86 13907920138, fxr0325@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.