NCT00508885

Brief Summary

Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
Last Updated

July 30, 2007

Status Verified

July 1, 2007

First QC Date

July 26, 2007

Last Update Submit

July 26, 2007

Conditions

Hyperphosphatemia

Keywords

hyperphosphatemianiacinamideESRDperitoneal dialysisrenal osteodystrophy

Outcome Measures

Primary Outcomes (1)

  • The change in plasma phosphorus after 8 weeks of niacinamide versus placebo

    8 weeks

Secondary Outcomes (1)

  • The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus

    8 weeks

Study Arms (2)

1

EXPERIMENTAL

Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily

Drug: Niacinamide

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NiacinamideDRUG

Niacinamide 250 mg twice daily titrated up to 750 mg twice daily

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Capable of giving informed consent
  • Duration of peritoneal dialysis \> 3 months
  • Dose of phosphate binder(s) stable over previous 2 week period
  • Plasma phosphours \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

You may not qualify if:

  • Pregnancy
  • Known liver disease
  • Active peptic ulcer disease
  • Treatment with carbamazepine
  • Intolerance to niacinamide or niacin
  • Current medication regimen including niacin or niacinamide \> 100 mg daily
  • Planned or expected surgical procedure in the next 4 months
  • Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • 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

  • Young DO, Cheng SC, Delmez JA, Coyne DW. The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int. 2009 Sep-Oct;29(5):562-7.

    PMID: 19776051DERIVED

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, ChronicChronic Kidney Disease-Mineral and Bone Disorder

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Daniel O Young, MD

    Washington University, Renal Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

October 1, 2006

Study Completion

July 1, 2007

Last Updated

July 30, 2007

Record last verified: 2007-07

Locations

US(1)