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The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis

Primary Purpose

Hyperphosphatemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Niacin
Phosphate Binder
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. end stage renal disease patients aged from 18-60 years old.
  2. Duration of Hemodialysis >6 months.
  3. Serum phosphorus level >5 mg/dl

Exclusion Criteria:

  • 1)patients on sevelamer or cinacalcet. 2)Hepatitis C virus +ve patients. 3)Connective tissue disease. 4)Active malignancy. 5) pregnancy 6) active peptic ulcer disease 7) treatment with carbamazepine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    patients received niacin 750 mg twice daily up to 2000 mg in addition to usual phosphate binders .

    patients received usual phosphate binders .

    Outcomes

    Primary Outcome Measures

    the level of phosphorous level in haemodialysis patients treated by niacin
    laboratory test

    Secondary Outcome Measures

    Full Information

    First Posted
    May 21, 2017
    Last Updated
    May 22, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03163576
    Brief Title
    The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis
    Official Title
    The Efficacy and Safety of Niacin on Hyperphosphatemia in End Stage Renal Disease Patients Undergoing Haemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2017 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hyperphosphatemia is a common complication of end-stage renal disease and particularly affects haemodialysis patients. Elevated serum phosphorus contributes to the development of secondary hyperparathyroidism, Mineral bone disorders,metastatic calcifications and calcific uremic arteriolopathy. There is a significant association between hyperphosphatemia and increased morbidity and mortality in end stage renal disease patients including cardiovascular morbidity and mortality ,also it's associated with hospitalization of haemodialysis patients.
    Detailed Description
    Hyperphosphataemia is mainly due to impaired renal phosphate excretion and primary increase in renal phosphate reabsorption,due to acute or chronic renal insufficiency. Renal excretion is so efficient in normal subjects that balance can be maintained with only a minimal rise in serum phosphorus concentration even for a large phosphorus load. Therefore, acute hyperphosphataemia usually resolves within few hours if renal function is intact. Although, there is multiple lines of treatment of hyperphosphatemia in end stage renal disease patients undergoing Hemodialysis but still inadequate. As Calcium containing phosphate binders may sometimes result in adverse effects such as hypercalcemia. Non-calcium containing phosphate binders, such as sevelamer and lanthanum, are expensive. Aluminum-containing agents are efficient but no longer widely used because of their toxicity. Several trials have shown that nicotinamide and niacin are capable of remarkably reducing serum phosphate levels in patients undergoing haemodialysis. Niacin is a water-soluble vitamin, and a part of the B complex vitamin, both nicotinamide and niacin (nicotinic acid) are forms of vitamin B3 . As a broad-spectrum drug that can affect lipid levels, niacin reduces levels of total cholesterol, triglyceride, and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol levels. Niacin also lowers serum phosphorus levels in patients with chronic kidney disease, dyslipidemia, and diabetes mellitus. Furthermore, niacin plays a key role in cardiovascular diseases and cardiovascular-related mortality by modifying both dyslipidemia and phosphorus levels. Recently, nicotinic acid and related compounds such as nicotinamide have also been shown to decrease phosphorus absorption in the gastro-intestinal tracts of animals by a different mechanism than the traditional phosphate binders. The major side effects of niacin are vasodilation and flushing, which appear to be mediated through prostaglandin production, and thus can be attenuated by premedication with aspirin.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    patients received niacin 750 mg twice daily up to 2000 mg in addition to usual phosphate binders .
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    patients received usual phosphate binders .
    Intervention Type
    Drug
    Intervention Name(s)
    Niacin
    Intervention Description
    tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Phosphate Binder
    Intervention Description
    tablets
    Primary Outcome Measure Information:
    Title
    the level of phosphorous level in haemodialysis patients treated by niacin
    Description
    laboratory test
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: end stage renal disease patients aged from 18-60 years old. Duration of Hemodialysis >6 months. Serum phosphorus level >5 mg/dl Exclusion Criteria: 1)patients on sevelamer or cinacalcet. 2)Hepatitis C virus +ve patients. 3)Connective tissue disease. 4)Active malignancy. 5) pregnancy 6) active peptic ulcer disease 7) treatment with carbamazepine.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanan Mahmoud Ahmed, MD
    Phone
    01065735355
    Email
    drhanan_abuelrus@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    essam Mohamed Abd el Aziz, MD
    Phone
    01009699081
    Email
    essam.nephro@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23526664
    Citation
    Rennick A, Kalakeche R, Seel L, Shepler B. Nicotinic acid and nicotinamide: a review of their use for hyperphosphatemia in dialysis patients. Pharmacotherapy. 2013 Jun;33(6):683-90. doi: 10.1002/phar.1258. Epub 2013 Mar 21.
    Results Reference
    background
    PubMed Identifier
    24000048
    Citation
    Lenglet A, Liabeuf S, Guffroy P, Fournier A, Brazier M, Massy ZA. Use of nicotinamide to treat hyperphosphatemia in dialysis patients. Drugs R D. 2013 Sep;13(3):165-73. doi: 10.1007/s40268-013-0024-6.
    Results Reference
    background
    PubMed Identifier
    23087550
    Citation
    Edalat-Nejad M, Zameni F, Talaiei A. The effect of niacin on serum phosphorus levels in dialysis patients. Indian J Nephrol. 2012 May;22(3):174-8. doi: 10.4103/0971-4065.98751.
    Results Reference
    background
    PubMed Identifier
    26889433
    Citation
    Jin Kang H, Kim DK, Mi Lee S, Han Kim K, Hee Han S, Hyun Kim K, Eun Kim S, Ki Son Y, An WS. Effects of low-dose niacin on dyslipidemia and serum phosphorus in patients with chronic kidney disease. Kidney Res Clin Pract. 2013 Mar;32(1):21-6. doi: 10.1016/j.krcp.2012.12.001. Epub 2012 Dec 31.
    Results Reference
    background
    PubMed Identifier
    23625273
    Citation
    Malberti F. Hyperphosphataemia: treatment options. Drugs. 2013 May;73(7):673-88. doi: 10.1007/s40265-013-0054-y.
    Results Reference
    background
    PubMed Identifier
    27512294
    Citation
    Zahed NS, Zamanifar N, Nikbakht H. Effect of low dose nicotinic acid on hyperphosphatemia in patients with end stage renal disease. Indian J Nephrol. 2016 Jul-Aug;26(4):239-43. doi: 10.4103/0971-4065.161020.
    Results Reference
    background

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    The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis

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