check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
11878
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Key Participants Requirements
Sex
BothAge
20 - 75 YearsTrial summary
Enrollment Goal
43Trial Dates
January 2006 - July 2006Phase
Phase 3Could I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kitasaito Hospital | Asahikawa, 070-0030, Japan |
Completed | Eijinkai Hospital | Osaki, 989-6117, Japan |
Completed | Sendai Shakaihoken Hospital | Sendai, 981-0912, Japan |
Completed | Tokyo Kyosai Hospital | Meguro-ku, 153-0061, Japan |
Completed | Shonan Kamakura General Hospital | Kamakura, 247-0072, Japan |
Completed | Yokosuka Kyosai Hospital | Yokosuka, 238-0011, Japan |
Completed | Gifu Prefectural General Medical Center | Gifu, 500-8717, Japan |
Completed | Okayama Saiseikai General Hospital | Okayama, 700-0013, Japan |
Completed | Tsuchiya General Hospital | Hiroshima, 730-8655, Japan |
Completed | Kawashima Hospital | Tokushima, 770-0011, Japan |
Completed | Fukuoka Red Cross Hospital | Fukuoka, 815-0082, Japan |
Primary Outcome
- Change from baseline in serum phosphate levels at the end of the treatment perioddate_rangeTime Frame:Baseline to Week 8enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievementdate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Serum calcium level corrected by serum albumin level at the end of the treatment perioddate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Serum calcium x phosphate product at the end of the treatment perioddate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Serum intact-PTH (Parathyroid) levels at the end of the treatment perioddate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:8 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1