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A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

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ClinicalTrials.gov Identifier: NCT01850641
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 29, 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 3, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PA21 Drug: PA21



Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  4. Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  5. TSAT at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  6. Hb Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 12 weeks ]
  7. Constipation Condition [ Time Frame: 12 weeks ]
  8. Satisfaction With Bowel Movement [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving stable maintenance hemodialysis 3 times a week
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01850641


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01850641     History of Changes
Other Study ID Numbers: PA1304
First Posted: May 9, 2013    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: November 2014
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Hemodialysis
Hyperphosphatemia
Additional relevant MeSH terms:
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Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases