A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

This study has been completed.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
First received: May 7, 2013
Last updated: November 11, 2014
Last verified: November 2014
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Condition Intervention Phase
Peritoneal Dialysis
Drug: PA21
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Serum phosphate concentrations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidences of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidences of Adverse Events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
  • Serum phosphate concentrations [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PA21 Drug: PA21


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Receiving stable maintenance peritoneal dialysis
  • Peritoneal 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01852682

Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01852682     History of Changes
Other Study ID Numbers: PA1303 
Study First Received: May 7, 2013
Last Updated: November 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Peritoneal Dialysis

Additional relevant MeSH terms:
Metabolic Diseases
Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on May 23, 2016