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Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia (NAHPH)

Primary Purpose

Hyperphosphatemia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Nicotinic Acids

Calcium Carbonate

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hemodialysis,Hyperphosphatemia,Nicotinic Acids

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jiujiang NO.1 People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

nicotinic acids group

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in serum phosphorus

Secondary Outcome Measures

change in serum calcium

change in serum calcium-phosphorus product

change in intact parathyroid hormone

change in alkaline phosphatase

change in platelet count

change in serum uric acid

change in serum glucose

change in total cholesterol

change in triglyceride

change in high density lipoprotein cholesterol

change in low density lipoprotein cholesterol

change in serum glutamic-pyruvic transaminase

change in glutamic oxalacetic transaminase

change in bilirubin

Full Information

NCT ID

NCT02836184

First Posted

July 14, 2016

Last Updated

August 29, 2016

Sponsor

Jiujiang No.1 People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02836184

Brief Title

Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

Acronym

NAHPH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jiujiang No.1 People's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia

Keywords

Hemodialysis,Hyperphosphatemia,Nicotinic Acids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Active Comparator

Arm Description

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

Arm Title

nicotinic acids group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nicotinic Acids

Other Intervention Name(s)

Niacin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Calcium Carbonate

Other Intervention Name(s)

Calcite

Intervention Description

Calcium Carbonate 500mg per oral, twice a day

Primary Outcome Measure Information:

Title

change in serum phosphorus

Time Frame