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The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis

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ClinicalTrials.gov Identifier: NCT03163576
Recruitment Status : Unknown
Verified May 2017 by EYAbdelhafez, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
EYAbdelhafez, Assiut University

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.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Niacin Drug: Phosphate Binder Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Niacin on Hyperphosphatemia in End Stage Renal Disease Patients Undergoing Haemodialysis
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study group
patients received niacin 750 mg twice daily up to 2000 mg in addition to usual phosphate binders .
Drug: Niacin
tablets

Drug: Phosphate Binder
tablets

Active Comparator: control group
patients received usual phosphate binders .
Drug: Phosphate Binder
tablets




Primary Outcome Measures :
  1. the level of phosphorous level in haemodialysis patients treated by niacin [ Time Frame: two years ]
    laboratory test



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03163576


Contacts
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Contact: Hanan Mahmoud Ahmed, MD 01065735355 drhanan_abuelrus@yahoo.com
Contact: essam Mohamed Abd el Aziz, MD 01009699081 essam.nephro@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: EYAbdelhafez, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03163576    
Other Study ID Numbers: ENPD
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs