NCT03163576

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2017

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 21, 2017

Last Update Submit

May 22, 2017

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • the level of phosphorous level in haemodialysis patients treated by niacin

    laboratory test

    two years

Study Arms (2)

study group

EXPERIMENTAL

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

Drug: NiacinDrug: Phosphate Binder

control group

ACTIVE COMPARATOR

patients received usual phosphate binders .

Drug: Phosphate Binder

Interventions

NiacinDRUG

tablets

study group
Phosphate BinderDRUG

tablets

control groupstudy group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • )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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 23526664BACKGROUND

  • 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.

    PMID: 24000048BACKGROUND

  • 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.

    PMID: 23087550BACKGROUND

  • 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.

    PMID: 26889433BACKGROUND

  • Malberti F. Hyperphosphataemia: treatment options. Drugs. 2013 May;73(7):673-88. doi: 10.1007/s40265-013-0054-y.

    PMID: 23625273BACKGROUND

  • 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.

    PMID: 27512294BACKGROUND

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Niacin

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Hanan Mahmoud Ahmed, MD

CONTACT

01065735355drhanan_abuelrus@yahoo.com

essam Mohamed Abd el Aziz, MD

CONTACT

01009699081essam.nephro@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share