Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary

Criteria

Inclusion Criteria:

• Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.

• Out-patient

• Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion Criteria:

• Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after

• Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after

• Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period

• Pregnant woman, or lactating mother

• Significant gastrointestinal disorders including known acute peptic ulcer

• Liver dysfunction

• History of cardiovascular or cerebrovascular diseases

• Requiring treatment for hypothyroidism