Status:
COMPLETED
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
Lead Sponsor:
Bayer
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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, parall...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT01514851
Start Date
January 1 2006
End Date
May 1 2006
Last Update
June 8 2012
Active Locations (31)
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1
Toyohashi, Aichi-ken, Japan, 441-8023
2
Yatomi, Aichi-ken, Japan, 498-0006
3
Asahi, Chiba, Japan, 289-2511
4
Chiba, Chiba, Japan, 261-0011