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A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

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ClinicalTrials.gov Identifier: NCT01850602
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 evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 23, 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 10, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PA21 Drug: PA21
Active Comparator: Sevelamer hydrochloride Drug: Sevelamer hydrochloride



Primary Outcome Measures :
  1. Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment [ Time Frame: 12 weeks ]
    Covariate: Serum phosphorus concentrations at baseline.


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 ]


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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 20 or older, regardless of gender.
  • Receiving stable maintenance hemodialysis 3 times a week.
  • Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

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): NCT01850602


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: NCT01850602     History of Changes
Other Study ID Numbers: PA1301
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
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action