A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Kissei

Status and phase: Completed; Phase 3

Conditions: Hemodialysis; Hyperphosphatemia

Treatments: Drug: PA21; Drug: Sevelamer hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01850602

PA1301

Details and patient eligibility

About

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

Enrollment: 213 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

213 participants in 2 patient groups

PA21

Experimental group

Treatment:

Drug: PA21

Sevelamer hydrochloride

Active Comparator group

Treatment:

Drug: Sevelamer hydrochloride