check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
11877
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Phase III double-blind comparative study of BAY77-1931 (Lanthanum Carbonate) with Calcium carbonate
Trial purpose
To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.
Key Participants Requirements
Sex
BothAge
20 YearsTrial summary
Enrollment Goal
259Trial Dates
January 2006 - May 2006Phase
Phase 3Could I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Mihama Hospital | Chiba, 261-0011, Japan |
Completed | Mihama Narita Clinic | Narita, 286-0041, Japan |
Completed | Shin Kashiwa Clinic | Kashiwa, 277-0084, Japan |
Completed | Sendai Shakaihoken Hospital | Sendai, 981-0912, Japan |
Completed | Meiyo Clinic | Toyohashi, 441-8023, Japan |
Completed | Ama Kyoritsu Clinic | Yatomi, 498-0006, Japan |
Completed | Shigei Medical Research Hospital | Okayama, 701-0202, Japan |
Completed | Nakajima Tsuchiya Clinic | Hiroshima, 730-0811, Japan |
Completed | Kawashima Hospital | Tokushima, 770-0011, Japan |
Completed | Kinashi-Obayashi Hospital | Takamatsu, 761-8024, Japan |
Completed | Shimazu Hospital | Kochi, 780-0066, Japan |
Completed | Tokai Hospital | Nerima-ku, 176-0023, Japan |
Completed | Maruyama Hospital | Hamamatsu, 430-0903, Japan |
Completed | Inoue Hospital | Suita, 564-0053, Japan |
Completed | Seseragi Hospital | Isesaki, 379-2211, Japan |
Completed | Eijinkai Hospital | Osaki, 989-6117, Japan |
Completed | Yuai Clinic | Saitama, 330-0854, Japan |
Completed | Yuai Nakagawa Clinic | Saitama, 337-0043, Japan |
Completed | Yuai Mihashi Clinic | Saitama, 330-0856, Japan |
Completed | Sumiyoshi Clinic Hospital | Mito, 310-0844, Japan |
Completed | Tsuchiurakyodo General Hospital | Tsuchiura, 300-0053, Japan |
Completed | Tokatsu Clinic Matsudo | Matsudo, 271-0077, Japan |
Completed | Asahi Central Hospital | Asahi, 289-2511, Japan |
Completed | Minami-senju Hospital | Arakawa-ku, 116-0003, Japan |
Completed | Shinjuku Koshin Clinic | Shinjyuku-ku, 160-0023, Japan |
Completed | Bosei Shinjuku South Clinic | Shibuya-ku, 151-0053, Japan |
Completed | Kodaira North Clinic | Kodaira, 187-0001, Japan |
Completed | Fuji First Clinic | Fuji, 417-0056, Japan |
Completed | Sumiyoshigawa Hospital | Kobe, 658-0084, Japan |
Completed | St.Mary's Hospital | Kurume, 830-8543, Japan |
Completed | Koga Clinic | Kurume, 830-8522, Japan |
Primary Outcome
- Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind perioddate_rangeTime Frame:baseline to week 8enhanced_encryptionNoSafety Issue:
- Presence/absence of incidence of hypercalcemia up to 8 weeksdate_rangeTime Frame:up to 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants achieving target PSPL and time to achievementdate_rangeTime Frame:up to 8 weeksenhanced_encryptionNoSafety Issue:
- Serum calcium x phosphate product at the end of the double-blind treatment perioddate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Serum intact-PTH (Parathyroid) levelsdate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Serum calcium level corrected by serum albumin level at the end of the double-blind treatment perioddate_rangeTime Frame:Week 8enhanced_encryptionNoSafety Issue:
- Number of participants achieving the target serum calcium levelsdate_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
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2