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Clinical Trials/NCT02805348
NCT02805348
Completed
Not Applicable

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

Astellas Pharma Inc14 sites in 1 country144 target enrollmentStarted: June 1, 2016Last updated:
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ConditionsChronic Kidney Disease
InterventionsBixalomer
DrugsBixalomer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
14
Primary Endpoint
Change from baseline in the serum concentrations of phosphate
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Chronic kidney disease

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

Intervention: Bixalomer (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (14)

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