Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

NCT ID: NCT01901107

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1078 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Detailed Description

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Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Conditions

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Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kiklin group

Kiklin capsules

Intervention Type DRUG

oral

Interventions

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Kiklin capsules

oral

Intervention Type DRUG

Other Intervention Names

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ASP1585 ILY101 AMG223 bixalomer

Eligibility Criteria

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Inclusion Criteria

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Chūbu, Chubu, Japan

Site Status

Chugoku, Chugoku, Japan

Site Status

Hokkaido, Hokkaido, Japan

Site Status

Kantou, Kantou, Japan

Site Status

Kinki, Kinki, Japan

Site Status

Kyusyu, Kyusyu, Japan

Site Status

Shikoku, Shikoku, Japan

Site Status

Tōhoku, Touhoku, Japan

Site Status

Countries

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Japan

Other Identifiers

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KIK001

Identifier Type: -

Identifier Source: org_study_id

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