PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-11

Study Completion Date

2012-07-03

Brief Summary

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To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

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Detailed Description

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Conditions

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Chronic Kidney Disease Requiring Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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PA21 750 mg/day

Group Type EXPERIMENTAL

PA21

Intervention Type DRUG

PA21 1500 mg/day

Group Type EXPERIMENTAL

PA21

Intervention Type DRUG

PA21 2250 mg/day

Group Type EXPERIMENTAL

PA21

Intervention Type DRUG

PA21 3000 mg/day

Group Type EXPERIMENTAL

PA21

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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PA21

Intervention Type DRUG

PA21

Intervention Type DRUG

PA21

Intervention Type DRUG

PA21

Intervention Type DRUG

Placebo

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