A Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

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

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

Brief Summary

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This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.

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Detailed Description

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Conditions

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Chronic Kidney Disease Renal Insufficiency Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASP1585 group

Group Type EXPERIMENTAL

ASP1585

Intervention Type DRUG

oral

placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

Interventions

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ASP1585

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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LY101 AMG223 bixalomer

Eligibility Criteria

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Inclusion Criteria

* Chronic kidney disease patients (eGFR \< 60 mL/min/1.73 m2)
* Serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl
* 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 within 6 months

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No