Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase III Study of PA21 in Peritoneal Dialysis 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: NCT01852682
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 7, 2013
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date November 13, 2014
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
Serum phosphate concentrations [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01852682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • Incidences of Adverse Events [ Time Frame: 12 weeks ]
  • Incidences of Adverse Events [ Time Frame: 28 weeks ]
  • Serum phosphate concentrations [ Time Frame: 28 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peritoneal Dialysis
  • Hyperphosphatemia
Intervention  ICMJE Drug: PA21
Study Arms  ICMJE Experimental: PA21
Intervention: Drug: PA21
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Receiving stable maintenance peritoneal dialysis
  • Peritoneal dialysis patients with hyperphosphatemia

Exclusion Criteria:

  • Patients having history of a pronounced brain / cardiovascular disorder
  • Patients having severe gastrointestinal disorders
  • Patients having severe hepatic disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852682
Other Study ID Numbers  ICMJE PA1303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP