Trial Condition(s):
Hyperphosphatemia
Open study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Bayer Identifier:
11878
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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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