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

Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02805348

Enrollment

144

Registered

2016-06-20

Start date

2016-06-01

Completion date

2018-12-31

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Kiklin, Bixalomer, Chronic Kidney Disease

Brief summary

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

Interventions

DRUGBixalomer

Oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the serum concentrations of phosphate	Baseline and up to Month 12
Change from baseline in the corrected serum concentrations of calcium	Baseline and up to Month 12
Change from baseline in the serum concentrations of intact parathyroid hormone	Baseline and up to Month 12
Safety assessed by incidence of adverse events	Up to Month 12

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026