PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

Chronic Kidney Disease Requiring Hemodialysis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521494
• Other study ID #: PA1201
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2012
• Est. completion date: July 3, 2012

Study information

• Verified date: November 2017
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 3, 2012
• Est. primary completion date: July 3, 2012
• 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

• Chronic Kidney Disease Requiring Hemodialysis
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• PA21

• PA21

• PA21

• PA21

• Placebo

Locations

Country	Name	City	State
Japan	Japan	Multiple Locations

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	Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.	Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.	6 weeks
Secondary	Change From Baseline in Serum Calcium Concentrations.		6 weeks
Secondary	Change From Baseline in Serum Intact-PTH Concentrations.		6 weeks