Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia (NAHPH)

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

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

Study Overview

• Status: Unknown
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Calcium Carbonate; Drug: Nicotinic Acids

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoran Feng, MD,PHD; Phone Number: +86 13907920138; Email: fxr0325@163.com

Study Locations

• China
  • Jiangxi
    • Jiujiang, Jiangxi, China, 332000
      • Recruiting
      • Jiujiang No.1 People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Calcium Carbonate; Calcium Carbonate 500mg per oral, twice a day; Other Names: Calcite
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.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiujiang No.1 People's Hospital
• Investigators: Principal Investigator: Xiaoran Feng, MD,PHD, Department of Nephrology, Jiujiang NO.1 People's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 18, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hemodialysis,Hyperphosphatemia,Nicotinic Acids
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Gastrointestinal Agents; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Antacids; Nicotinic Acids; Calcium Carbonate; Niacinamide; Niacin
• Other Study ID Numbers: 2016075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No