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

Bayer123 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Hyperphosphatemia

Interventions

Fosrenol (Lanthanum Carbonate, BAY77-1931)DRUG

Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events

Time frame: baseline to Week 60

Data from ClinicalTrials.gov

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Unnamed facility

Anjo, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Seto, Aichi-ken, Japan

Unnamed facility

Toyohashi, Aichi-ken, Japan

Unnamed facility

Yatomi, Aichi-ken, Japan

Unnamed facility

Kamogawa, Chiba, Japan

Unnamed facility

Kisarazu, Chiba, Japan

...and 30 more locations