Clinical trial NCT02836184: Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia
Official title: The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperphosphatemia
Keywords: Hemodialysis,Hyperphosphatemia,Nicotinic Acids
Lead sponsor: Jiujiang No.1 People's Hospital
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: change in serum phosphorus
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
Secondary outcomes:
measure: change in serum calcium
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in serum calcium-phosphorus product
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in intact parathyroid hormone
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in alkaline phosphatase
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in platelet count
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in serum uric acid
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in serum glucose
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in total cholesterol
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in triglyceride
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in high density lipoprotein cholesterol
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in low density lipoprotein cholesterol
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in serum glutamic-pyruvic transaminase
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in glutamic oxalacetic transaminase
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
measure: change in bilirubin
timeFrame: Immediately after wash-out period and after 6 weeks of therapy.
Other outcomes:
Locations:
city: Jiujiang
country: China
facility: Jiujiang NO.1 People's Hospital
state: Jiangxi
Study officials:
affiliation: Department of Nephrology, Jiujiang NO.1 People's Hospital
name: Xiaoran Feng, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: