A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

Kissei Pharmaceutical Co., Ltd.

Overview

The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Peritoneal Dialysis Hyperphosphatemia

Interventions

PA21DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Receiving stable maintenance peritoneal dialysis * Peritoneal dialysis patients with hyperphosphatemia 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

Tokyo and Other Japanese City, Japan

Outcomes

Primary Outcomes

Serum phosphate concentrations

Time frame: 12 weeks

Secondary Outcomes

Incidences of Adverse Events

Time frame: 12 weeks

Incidences of Adverse Events

Time frame: 28 weeks

Serum phosphate concentrations

Time frame: 28 weeks

Data from ClinicalTrials.gov

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