Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Bayer

Status and phase: Completed; Phase 3

Conditions: Hyperphosphatemia

Treatments: Drug: Lanthanum Carbonate (BAY77-1931)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518387

11878

Details and patient eligibility

About

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Enrollment: 43 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
• Out-patient
• Undergoing CAPD for at least previous 3 consecutive months

Exclusion criteria

• Who may not enable to continue CAPD
• Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
• Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Arm 1

Experimental group

Description:

750-2250mg/day, tid, 8 weeks

Treatment:

Drug: Lanthanum Carbonate (BAY77-1931)