PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

This study has been completed.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: January 26, 2012
Last updated: November 29, 2012
Last verified: January 2012
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:

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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01521494

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

No publications provided

Responsible Party: Kissei Pharmaceutical Co., Ltd. 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.:

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Metabolic Diseases
Phosphorus Metabolism Disorders
Renal Insufficiency
Urologic Diseases processed this record on November 27, 2015