Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

NCT ID: NCT01514851

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-05-31

Brief Summary

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.

Conditions

Hyperphosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

750-2250mg/day, tid (three times a day), 8 weeks

Group Type: EXPERIMENTAL

Lanthanum carbonate (BAY77-1931)

Intervention Type: DRUG

Arm 2

1500-4500mg/day, tid, 8 weeks

Group Type: ACTIVE_COMPARATOR

Calcium carbonate

Intervention Type: DRUG

Interventions

Lanthanum carbonate (BAY77-1931)

Intervention Type: DRUG

Calcium carbonate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Yakuhin Ltd.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Toyohashi, Aichi-ken, Japan

Yatomi, Aichi-ken, Japan

Asahi, Chiba, Japan

Chiba, Chiba, Japan

Kashiwa, Chiba, Japan

Matsudo, Chiba, Japan

Narita, Chiba, Japan

Kurume, Fukuoka, Japan

Kurume, Fukuoka, Japan

Isesaki, Gunma, Japan

Hiroshima, Hiroshima, Japan

Kobe, Hyōgo, Japan

Mito, Ibaraki, Japan

Tsuchiura, Ibaraki, Japan

Takamatsu, Kagawa-ken, Japan

Kochi, Kochi, Japan

Ōsaki, Miyagi, Japan

Sendai, Miyagi, Japan

Okayama, Okayama-ken, Japan

Suita, Osaka, Japan

Saitama, Saitama, Japan

Saitama, Saitama, Japan

Saitama, Saitama, Japan

Fuji, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Tokushima, Tokushima, Japan

Arakawa-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Nerima-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinjyuku-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

11877

Identifier Type: -

Identifier Source: org_study_id