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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852682
First Posted: May 14, 2013
Last Update Posted: November 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Incidences of Adverse Events [ Time Frame: 12 weeks ]
  • Incidences of Adverse Events [ Time Frame: 28 weeks ]
  • Serum phosphate concentrations [ Time Frame: 28 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852682


Locations
Japan
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
First Submitted: May 7, 2013
First Posted: May 14, 2013
Last Update Posted: November 13, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases