Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

N/ACompletedNCT02805348

Astellas Pharma Inc144 enrolled

Overview

The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.

Study Type

OBSERVATIONAL

Enrollment

144

Oral

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Site JP00006

Aichi, Japan

Site JP00010

Ehime, Japan

Site JP00012

Fukuoka, Japan

Site JP00004

Gifu, Japan

Change from baseline in the serum concentrations of phosphate

Time frame: Baseline and up to Month 12

Change from baseline in the corrected serum concentrations of calcium

Time frame: Baseline and up to Month 12

Change from baseline in the serum concentrations of intact parathyroid hormone

Time frame: Baseline and up to Month 12

Safety assessed by incidence of adverse events

Time frame: Up to Month 12

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