Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

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

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period

• Out-patient

• Undergoing CAPD for at least previous 3 consecutive months

Exclusion Criteria:

• Who may not enable to continue CAPD

• Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after

• Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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