Status:
COMPLETED
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Lead Sponsor:
Bayer
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01518387
Start Date
January 1 2006
End Date
July 1 2006
Last Update
March 14 2016
Active Locations (11)
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1
Fukuoka, Fukuoka, Japan, 815-0082
2
Gifu, Gifu, Japan, 500-8717
3
Hiroshima, Hiroshima, Japan, 730-8655
4
Asahikawa, Hokkaido, Japan, 070-0030