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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014