Phase 1 N=39 Randomized Triple-blind Treatment

Healthy Combine Study

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03136705 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Change in Intact FGF23 — 1.001; 1.006; 1.009; 1.005 pg/ml — p=0.3738

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Nicotinamide (Drug); Lanthanum Carbonate (Drug); Lanthanum Carbonate Placebo (Drug); Nicotinamide Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Intact FGF23	1.001; 1.006; 1.009; 1.005	0.3738
SECONDARY Change in Plasma Phosphorus Level	0.0099; -0.0102; 0.0099; 0.0004	0.854
SECONDARY Change in 24 Hour Urinary Phosphorus Level	-10.24; -5.88; 1.29; -10.85	0.0648

Summary

STUDY SUMMARY Title: EFFECTS OF NICOTINAMIDE AND LANTHANUM CARBONATE ON PHOSPHORUS HOMEOSTASIS Protocol Number:STU00090161 Phase: Phase 1, detailed physiologic study Methodology: double blind, randomized, placebo-controlled, 2x2 factorial Study Duration: 12-18 months (to complete the entire study protocol) Study Center: Single-center Objectives: Define short-term effects of the interventions (lanthanum carbonate and nicotinamide) on indices of phosphate handling Number of Subjects: 80 Diagnosis and Main Inclusion Criteria: Healthy volunteers Study Product(s), Dose,Route, Regimen: Nicotinamide, 750 mg by mouth twice daily, Lanthanum carbonate, Fosrenol, 1000 mg by mouth three times daily with meals Duration of administration: 2 weeks (length of time study participants are enrolled in study) Reference therapy: reference is a placebo Statistical Methodology: Repeated measures analysis using mixed linear models

Eligibility Criteria

INCLUSION CRITERIA

Healthy volunteers

Age ≥ 18 years, at the time of screening

Normal renal function at screening, as defined by

eGFR > 60
no albuminuria
normal urinalysis
normotensive, defined as blood pressure 14 drinks/week
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or alkaline phosphatase concentrations > 2 times the upper limit of the local laboratory reference range and/or total bilirubin concentration not within institutional limits.

Creatine kinase (CK) concentrations > 2 times the upper limit of the local laboratory reference range at screening

Major hemorrhagic event within the past six months from screening requiring inpatient admission.

Blood or platelet transfusion within the past six months from screening

History of primary hyperparathyroidism

Current, clinically significant malabsorption

Anemia (screening HCT 100 mg/day

Current or recent use of MVI containing niacin/nicotinamide > 100 mg/day

Current use of Tums (or calcium carbonate taken for indigestion) at a dose of >1000 mg daily

Current participation in another clinical trial or other interventional research

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03136705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.