Trial Condition(s):
Hyperphosphatemia
Open study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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 |
Trial Design
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
Primary Outcome
- Change from baseline in serum phosphate levels at the end of the treatment periodTimeframe: Baseline to Week 8
Secondary Outcome
- Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievementTimeframe: Week 8
- Serum calcium level corrected by serum albumin level at the end of the treatment periodTimeframe: Week 8
- Serum calcium x phosphate product at the end of the treatment periodTimeframe: Week 8
- Serum intact-PTH (Parathyroid) levels at the end of the treatment periodTimeframe: Week 8
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: 8 weeks
Additional Information
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