A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Phase 3

Completed

• Conditions: Hyperphosphatemia; Hemodialysis
• Interventions: Drug: PA21; Drug: Sevelamer hydrochloride

• Registration Number: NCT01850602
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-23
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Primary Completion: 2013-12
• Study Completion: 2013-12-10
• Status Verified: 2014-11
• 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: 213

Inclusion Criteria

• Patients age 20 or older, regardless of gender.
• Receiving stable maintenance hemodialysis 3 times a week.
• Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA21	PA21	-
Sevelamer hydrochloride	Sevelamer hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment	12 weeks	Covariate: Serum phosphorus concentrations at baseline.

Secondary Outcome Measures

Name	Time	Method
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)	12 weeks
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)	12 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)	12 weeks