A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

Hemodialysis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850602
• Other study ID #: PA1301
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2013
• Est. completion date: December 10, 2013

Study information

• Verified date: November 2014
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 10, 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis
• Hyperphosphatemia

Intervention

Drug:
• PA21

• Sevelamer hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment	Covariate: Serum phosphorus concentrations at baseline.	12 weeks
Secondary	Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)		12 weeks
Secondary	Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)		12 weeks
Secondary	Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)		12 weeks