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

This study is currently recruiting participants.
Verified May 2013 by Kissei Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01852682
First received: May 7, 2013
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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
Hyperphosphatemia
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

Resource links provided by NLM:


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 ]

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01852682

Contacts
Contact: Kissei Pharmaceutical Co., Ltd rinsyousiken@pharm.kissei.co.jp

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

No publications provided

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: May 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014