PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Phase 2CompletedNCT01521494

Kissei Pharmaceutical Co., Ltd.183 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

183

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Interventions

PA21DRUG

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)

Japan

Multiple Locations, Japan

Outcomes

Primary Outcomes

Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.

Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.

Time frame: 6 weeks

Secondary Outcomes

Change From Baseline in Serum Calcium Concentrations.

Time frame: 6 weeks

Change From Baseline in Serum Intact-PTH Concentrations.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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