A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Phase 3

Completed

• Conditions: Hemodialysis Patients With Hyperphosphatemia
• Interventions: Drug: PA21

• Registration Number: NCT01833494
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-18
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Primary Completion: 2014-08
• Study Completion: 2014-08-04
• Status Verified: 2015-04
• Results First Submitted: 2018-03-02
• Results First Submitted QC: 2018-03-02
• Last Update Submitted: 2018-03-02
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

• Receiving stable maintenance hemodialysis 3 times a week.
• 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
Incidence of Adverse Events	52 weeks

Secondary Outcome Measures

Name	Time	Method
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)	52 weeks
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)	52 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)	52 weeks

Trial Locations

Locations (1)

JAPAN; 🇯🇵 Multiple Locations, Japan