Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Bayer

Status and phase: Completed; Phase 3

Conditions: Hyperphosphatemia

Treatments: Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01187628

15074

Details and patient eligibility

About

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Enrollment: 123 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

Exclusion criteria

• Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)