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