Trial Condition(s):
Open study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
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.
- 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
- 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
Locations | Status | ||
---|---|---|---|
Locations Kitasaito Hospital Asahikawa, Japan, 070-0030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Eijinkai Hospital Osaki, Japan, 989-6117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Sendai Shakaihoken Hospital Sendai, Japan, 981-0912 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Tokyo Kyosai Hospital Meguro-ku, Japan, 153-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-0072 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Yokosuka Kyosai Hospital Yokosuka, Japan, 238-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Gifu Prefectural General Medical Center Gifu, Japan, 500-8717 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Okayama Saiseikai General Hospital Okayama, Japan, 700-0013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Tsuchiya General Hospital Hiroshima, Japan, 730-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Kawashima Hospital Tokushima, Japan, 770-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Fukuoka Red Cross Hospital Fukuoka, Japan, 815-0082 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Phase III open study of BAY 77 1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis (CAPD)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1