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PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01521494
First received: January 26, 2012
Last updated: November 29, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in serum calcium concentrations. [ Designated as safety issue: No ]
  • Change from baseline in serum calcium × phosphate product. [ Designated as safety issue: No ]
  • Change from baseline in serum intact-PTH concentrations. [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01521494     History of Changes
Other Study ID Numbers: PA1201
Study First Received: January 26, 2012
Last Updated: November 29, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 16, 2013