Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Hyperphosphatemia Clinical Trial

— NAHPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836184
• Other study ID #: 2016075
• Status: Recruiting
• Phase: Phase 4
• First received: July 14, 2016
• Last updated: August 29, 2016
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Jiujiang No.1 People's Hospital
• Contact: Xiaoran Feng, MD,PHD
• Phone: +86 13907920138
• Email: fxr0325[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

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.
• Calcium Carbonate
Calcium Carbonate 500mg per oral, twice a day

Locations

Country	Name	City	State
China	Jiujiang NO.1 People's Hospital	Jiujiang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiujiang No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in serum phosphorus		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in serum calcium		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in serum calcium-phosphorus product		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in intact parathyroid hormone		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in alkaline phosphatase		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in platelet count		Immediately after wash-out period and after 6 weeks of therapy.	Yes
Secondary	change in serum uric acid		Immediately after wash-out period and after 6 weeks of therapy.	Yes
Secondary	change in serum glucose		Immediately after wash-out period and after 6 weeks of therapy.	Yes
Secondary	change in total cholesterol		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in triglyceride		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in high density lipoprotein cholesterol		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in low density lipoprotein cholesterol		Immediately after wash-out period and after 6 weeks of therapy.	No
Secondary	change in serum glutamic-pyruvic transaminase		Immediately after wash-out period and after 6 weeks of therapy.	Yes
Secondary	change in glutamic oxalacetic transaminase		Immediately after wash-out period and after 6 weeks of therapy.	Yes
Secondary	change in bilirubin		Immediately after wash-out period and after 6 weeks of therapy.	Yes