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PA21 Phase II Clinical Study in Hemodialysis 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.
 
ClinicalTrials.gov Identifier: NCT01521494
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Requiring Hemodialysis Drug: PA21 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Study Start Date : January 11, 2012
Actual Primary Completion Date : July 3, 2012
Actual Study Completion Date : July 3, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PA21 750 mg/day Drug: PA21
Experimental: PA21 1500 mg/day Drug: PA21
Experimental: PA21 2250 mg/day Drug: PA21
Experimental: PA21 3000 mg/day Drug: PA21
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment. [ Time Frame: 6 weeks ]
    Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.


Secondary Outcome Measures :
  1. Change From Baseline in Serum Calcium Concentrations. [ Time Frame: 6 weeks ]
  2. Change From Baseline in Serum Intact-PTH Concentrations. [ Time Frame: 6 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): NCT01521494


Locations
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Japan
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Tatsuro Takei Clinical Development Department, Kissei pharmaceutical Co., Ltd.

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01521494     History of Changes
Other Study ID Numbers: PA1201
First Posted: January 30, 2012    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018
Last Verified: November 2017
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Hemodialysis
Hyperphosphatemia
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases