A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

Kissei

Status and phase: Completed; Phase 3

Conditions: Hemodialysis; Hyperphosphatemia

Treatments: Drug: PA21

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850641

PA1304

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receiving stable maintenance hemodialysis 3 times a week
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

PA21

Experimental group

Treatment:

Drug: PA21