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PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521494
First Posted: January 30, 2012
Last Update Posted: November 29, 2017
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
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Condition Intervention Phase
Chronic Kidney Disease Requiring Hemodialysis Drug: PA21 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline in serum phosphate concentrations at final evaluation. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Change from baseline in serum calcium concentrations.
  • Change from baseline in serum calcium × phosphate product.
  • Change from baseline in serum intact-PTH concentrations.

Estimated Enrollment: 150
Arms Assigned Interventions
Experimental: PA21 Dose 1 Drug: PA21
Experimental: PA21 Dose 2 Drug: PA21
Experimental: PA21 Dose 3 Drug: PA21
Experimental: PA21 Dose 4 Drug: PA21
Placebo Comparator: Placebo Drug: Placebo

  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
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.
  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): NCT01521494


Locations
Japan
Japan
Tokyo and Other Japanese City, Japan, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
Study Director: Tatsuro Takei Clinical Development Department, Kissei pharmaceutical Co., Ltd.
  More Information

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01521494     History of Changes
Other Study ID Numbers: PA1201
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: November 29, 2017
Last Verified: January 2012

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Hemodialysis
Hyperphosphatemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases