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
About this trial
This is an interventional treatment trial for Hyperphosphatemia
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.
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
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
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The Efficacy of Niacin on Hyperphosphatemia in Patients Undergoing Haemodialysis
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