BAY 77-1931 Long-term Extension From Phase II Study

Bayer

Status and phase: Completed; Phase 2

Conditions: Hyperphosphatemia

Treatments: Drug: BAY 77-1931

Study type: Interventional

Funder types: Industry

Identifiers

NCT00769496

11551 (Registry Identifier)

Details and patient eligibility

About

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Enrollment: 145 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion criteria

• Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: BAY 77-1931