Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia (NAHPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836184
Recruitment Status : Unknown
Verified July 2016 by Xiaoran Feng, Jiujiang No.1 People's Hospital.
Recruitment status was:  Recruiting
First Posted : July 18, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaoran Feng, Jiujiang No.1 People's Hospital

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

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Nicotinic Acids Drug: Calcium Carbonate Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
Study Start Date : July 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Niacin




Primary Outcome Measures :
  1. change in serum phosphorus [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]

Secondary Outcome Measures :
  1. change in serum calcium [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  2. change in serum calcium-phosphorus product [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  3. change in intact parathyroid hormone [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  4. change in alkaline phosphatase [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  5. change in platelet count [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  6. change in serum uric acid [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  7. change in serum glucose [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  8. change in total cholesterol [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  9. change in triglyceride [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  10. change in high density lipoprotein cholesterol [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  11. change in low density lipoprotein cholesterol [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  12. change in serum glutamic-pyruvic transaminase [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  13. change in glutamic oxalacetic transaminase [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]
  14. change in bilirubin [ Time Frame: Immediately after wash-out period and after 6 weeks of therapy. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836184


Contacts
Layout table for location contacts
Contact: Xiaoran Feng, MD,PHD +86 13907920138 fxr0325@163.com

Locations
Layout table for location information
China, Jiangxi
Jiujiang NO.1 People's Hospital Recruiting
Jiujiang, Jiangxi, China, 332000
Sponsors and Collaborators
Jiujiang No.1 People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xiaoran Feng, MD,PHD Department of Nephrology, Jiujiang NO.1 People's Hospital

Layout table for additonal information
Responsible Party: Xiaoran Feng, deputy director of nephrology division, Jiujiang No.1 People's Hospital
ClinicalTrials.gov Identifier: NCT02836184     History of Changes
Other Study ID Numbers: 2016075
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiaoran Feng, Jiujiang No.1 People's Hospital:
Hemodialysis,Hyperphosphatemia,Nicotinic Acids
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Nicotinic Acids
Niacin
Niacinamide
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents