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

Bayer

Status and phase: Completed; Phase 3

Conditions: Hyperphosphatemia

Treatments: Drug: Calcium carbonate; Drug: Lanthanum carbonate (BAY77-1931)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514851

11877

Details and patient eligibility

About

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.

Enrollment: 259 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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259 participants in 2 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Lanthanum carbonate (BAY77-1931)

Arm 2

Active Comparator group

Description:

1500-4500mg/day, tid, 8 weeks

Treatment:

Drug: Calcium carbonate