PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Kissei

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease Requiring Hemodialysis

Treatments: Drug: Placebo; Drug: PA21

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521494

PA1201

Details and patient eligibility

About

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

Enrollment: 183 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: Double Blind

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183 participants in 5 patient groups, including a placebo group

PA21 750 mg/day

Experimental group

Treatment:

Drug: PA21

Drug: PA21

Drug: PA21

Drug: PA21

PA21 1500 mg/day

Experimental group

Treatment:

Drug: PA21

Drug: PA21

Drug: PA21

Drug: PA21

PA21 2250 mg/day

Experimental group

Treatment:

Drug: PA21

Drug: PA21

Drug: PA21

Drug: PA21

PA21 3000 mg/day

Experimental group

Treatment:

Drug: PA21

Drug: PA21

Drug: PA21

Drug: PA21

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo