Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

NCT02836184 | Unknown Phase 4

• 1 other identifier: 2016075
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperphosphatemia

Keywords

Hemodialysis,Hyperphosphatemia,Nicotinic Acids

Outcome Measures

Primary Outcomes (1)

• change in serum phosphorus

  Immediately after wash-out period and after 6 weeks of therapy.

Secondary Outcomes (14)

• 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.

Study Arms (2)

control group

ACTIVE COMPARATOR

Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out.

Drug: Calcium Carbonate

nicotinic acids group

EXPERIMENTAL

Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out.

Drug: Nicotinic Acids

Interventions

Nicotinic Acids DRUG

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

nicotinic acids group

Calcium Carbonate DRUG

Calcium Carbonate 500mg per oral, twice a day

Also known as: Calcite

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiujiang No.1 People's Hospital: lead

Study Sites (1)

Jiujiang NO.1 People's Hospital

Jiujiang, Jiangxi, 332000, China

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Nicotinic Acids; Niacin; Calcium Carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Xiaoran Feng, MD,PHD

  Department of Nephrology, Jiujiang NO.1 People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoran Feng, MD,PHD

CONTACT

+86 13907920138; fxr0325@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director of nephrology division

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 18, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)