A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Kissei

Status and phase: Completed; Phase 3

Conditions: Hemodialysis Patients With Hyperphosphatemia

Treatments: Drug: PA21

Study type: Interventional

Funder types: Industry

Identifiers

NCT01833494

PA1302

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

Enrollment: 161 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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161 participants in 1 patient group

PA21

Experimental group

Treatment:

Drug: PA21