A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

Hemodialysis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850641
• Other study ID #: PA1304
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2013
• Est. completion date: December 3, 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 investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 3, 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Hyperphosphatemia

Intervention

Drug:
• PA21

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	Incidence of Adverse Events		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
Secondary	Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)		12 weeks
Secondary	TSAT at End of Treatment (Actual Measured Value)		12 weeks
Secondary	Hb Concentrations at End of Treatment (Actual Measured Value)		12 weeks
Secondary	Constipation Condition		12 weeks
Secondary	Satisfaction With Bowel Movement		12 weeks