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

Phase 3

Completed

• Conditions: Peritoneal Dialysis; Hyperphosphatemia
• Interventions: Drug: PA21

• Registration Number: NCT01852682
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-14
• Primary Completion: 2014-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PA21	PA21	-

Primary Outcome Measures

Name	Time	Method
Serum phosphate concentrations	12 weeks

Secondary Outcome Measures

Name	Time	Method
Incidences of Adverse Events	28 weeks
Serum phosphate concentrations	28 weeks