A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

NCT ID: NCT01017276

Last Updated: 2015-05-04

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

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

Detailed Description

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Conditions

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Chronic Kidney Disease Renal Dialysis Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP group

Group Type EXPERIMENTAL

ASP1585

Intervention Type DRUG

oral

Interventions

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ASP1585

oral

Intervention Type DRUG

Other Intervention Names

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ILY101 AMG223

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease patients on peritoneal dialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.
* Written informed consent

Exclusion Criteria

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention
Minimum Eligible Age

20 Years

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_CHAIR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Kantou, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1585-CL-0005

Identifier Type: -

Identifier Source: org_study_id

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