A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP group

Group Type EXPERIMENTAL

ASP1585

Intervention Type DRUG

oral

Sevelamer group

Group Type ACTIVE_COMPARATOR

Sevelamer hydrochloride

Intervention Type DRUG

oral

Interventions

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ASP1585

oral

Intervention Type DRUG

Sevelamer hydrochloride

oral

Intervention Type DRUG

Other Intervention Names

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ILY101 AMG223 Renagel phosbloc

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease patients on hemodialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been 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