Trial Condition(s):
Hyperphosphatemia
Phase III double-blind comparative study of BAY77-1931 (Lanthanum Carbonate) with Calcium carbonate
Bayer Identifier:
11877
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period. - Out-patient - Undergoing hemodialysis three times per week for at least previous 3 consecutive months
Exclusion Criteria
- Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after - Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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 - Requiring treatment for hypothyroidism
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Mihama Hospital Chiba, Japan, 261-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mihama Narita Clinic Narita, Japan, 286-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shin Kashiwa Clinic Kashiwa, Japan, 277-0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sendai Shakaihoken Hospital Sendai, Japan, 981-0912 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meiyo Clinic Toyohashi, Japan, 441-8023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ama Kyoritsu Clinic Yatomi, Japan, 498-0006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shigei Medical Research Hospital Okayama, Japan, 701-0202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nakajima Tsuchiya Clinic Hiroshima, Japan, 730-0811 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kawashima Hospital Tokushima, Japan, 770-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinashi-Obayashi Hospital Takamatsu, Japan, 761-8024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shimazu Hospital Kochi, Japan, 780-0066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokai Hospital Nerima-ku, Japan, 176-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maruyama Hospital Hamamatsu, Japan, 430-0903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inoue Hospital Suita, Japan, 564-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seseragi Hospital Isesaki, Japan, 379-2211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eijinkai Hospital Osaki, Japan, 989-6117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yuai Clinic Saitama, Japan, 330-0854 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yuai Nakagawa Clinic Saitama, Japan, 337-0043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yuai Mihashi Clinic Saitama, Japan, 330-0856 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sumiyoshi Clinic Hospital Mito, Japan, 310-0844 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tsuchiurakyodo General Hospital Tsuchiura, Japan, 300-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokatsu Clinic Matsudo Matsudo, Japan, 271-0077 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asahi Central Hospital Asahi, Japan, 289-2511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Minami-senju Hospital Arakawa-ku, Japan, 116-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinjuku Koshin Clinic Shinjyuku-ku, Japan, 160-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bosei Shinjuku South Clinic Shibuya-ku, Japan, 151-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kodaira North Clinic Kodaira, Japan, 187-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fuji First Clinic Fuji, Japan, 417-0056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sumiyoshigawa Hospital Kobe, Japan, 658-0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.Mary's Hospital Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koga Clinic Kurume, Japan, 830-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase III double-blind comparative study of BAY 77 1931 (Lanthanum Carbonate) with a calcium carbonate in patients with hyperphosphatemia undergoing hemodialysis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind periodTimeframe: baseline to week 8
- Presence/absence of incidence of hypercalcemia up to 8 weeksTimeframe: up to 8 weeks
Secondary Outcome
- Number of participants achieving target PSPL and time to achievementTimeframe: up to 8 weeks
- Serum calcium x phosphate product at the end of the double-blind treatment periodTimeframe: Week 8
- Serum intact-PTH (Parathyroid) levelsTimeframe: Week 8
- Serum calcium level corrected by serum albumin level at the end of the double-blind treatment periodTimeframe: Week 8
- Number of participants achieving the target serum calcium levelsTimeframe: Week 8
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: 8 weeks
Additional Information
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