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

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. Identifier: NCT01852682
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 13, 2014
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Hyperphosphatemia Drug: PA21 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PA21 Drug: PA21

Primary Outcome Measures :
  1. Serum phosphate concentrations [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidences of Adverse Events [ Time Frame: 12 weeks ]
  2. Incidences of Adverse Events [ Time Frame: 28 weeks ]
  3. Serum phosphate concentrations [ Time Frame: 28 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

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 identifier (NCT number): NCT01852682

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Tokyo and Other Japanese City, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
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Responsible Party: Kissei Pharmaceutical Co., Ltd. Identifier: NCT01852682    
Other Study ID Numbers: PA1303
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Peritoneal Dialysis
Additional relevant MeSH terms:
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Phosphorus Metabolism Disorders
Metabolic Diseases