PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Phase 2

Completed

• Conditions: Chronic Kidney Disease Requiring Hemodialysis
• Interventions: Drug: Placebo; Drug: PA21

• Registration Number: NCT01521494
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Primary Completion: 2012-07-03
• Study Completion: 2012-07-03
• Status Verified: 2017-11
• Results First Submitted: 2017-11-27
• Results First Submitted QC: 2017-11-27
• Last Update Submitted: 2017-11-27
• Results First Posted: 2018-08-23
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PA21 1500 mg/day	PA21	-
PA21 3000 mg/day	PA21	-
PA21 2250 mg/day	PA21	-
PA21 750 mg/day	PA21	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.	6 weeks	Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Serum Calcium Concentrations.	6 weeks
Change From Baseline in Serum Intact-PTH Concentrations.	6 weeks

Trial Locations

Locations (1)

Japan; 🇯🇵 Multiple Locations, Japan

Japan

🇯🇵Multiple Locations, Japan