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Clinical Trials/NCT01852682
NCT01852682CompletedPhase 3

A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

Kissei Pharmaceutical Co., Ltd.0 sitesStarted: May 14, 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Primary Endpoint
Serum phosphate concentrations
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Receiving stable maintenance peritoneal dialysis
  • •Peritoneal dialysis patients with hyperphosphatemia

Exclusion Criteria

  • •Patients having history of a pronounced brain / cardiovascular disorder
  • •Patients having severe gastrointestinal disorders
  • •Patients having severe hepatic disorders

Arms & Interventions

PA21

Experimental

Intervention: PA21 (Drug)

Outcomes

Primary Outcomes

Serum phosphate concentrations

Time Frame: 12 weeks

Secondary Outcomes

  • Incidences of Adverse Events(28 weeks)
  • Serum phosphate concentrations(28 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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