A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

NCT ID: NCT01850602

Last Updated: 2018-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-23

Study Completion Date

2013-12-10

Brief Summary

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

Detailed Description

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Conditions

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Hemodialysis Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PA21

Group Type EXPERIMENTAL

PA21

Intervention Type DRUG

Sevelamer hydrochloride

Group Type ACTIVE_COMPARATOR

Sevelamer hydrochloride

Intervention Type DRUG

Interventions

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PA21

Intervention Type DRUG

Sevelamer hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

References

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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Other Identifiers

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PA1301

Identifier Type: -

Identifier Source: org_study_id

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