A Phase 4 interventional study of Nicotinic Acids and Calcium Carbonate in Hyperphosphatemia, sponsored by Jiujiang No.1 People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by Jiujiang No.1 People's Hospital · Phase 4, Interventional, and Treatment
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
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.
148 studies on the registry are indexed under Hyperphosphatemia; 10 are open to participants now.
This study's planned enrollment of 45 is below the median of 110 across 124 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Jiujiang No.1 People's Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out.
Drug: Calcium Carbonate
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.
Also known as: Niacin
Calcium Carbonate 500mg per oral, twice a day
Also known as: Calcite
change in serum phosphorus
Time frame: Immediately after wash-out period and after 6 weeks of therapy.
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.
Plan to share: No
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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Jiujiang No.1 People's Hospital