A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Kissei Pharmaceutical Co., Ltd.213 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

213

Conditions

Hemodialysis Hyperphosphatemia

Interventions

PA21DRUG

Sevelamer hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment

Covariate: Serum phosphorus concentrations at baseline.

Time frame: 12 weeks

Secondary Outcomes

Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)

Time frame: 12 weeks

Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)

Time frame: 12 weeks

Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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