Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-term Study of PA21 in Hemodialysis 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: NCT01833494
Recruitment Status : Completed
First Posted : April 17, 2013
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with hyperphosphatemia.

Condition or disease Intervention/treatment Phase
Hemodialysis Patients With Hyperphosphatemia Drug: PA21 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Actual Study Start Date : March 18, 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 4, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PA21 Drug: PA21



Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 52 weeks ]
  2. Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 52 weeks ]
  3. Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving stable maintenance hemodialysis 3 times a week.
  • 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.

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): NCT01833494


Locations
Layout table for location information
Japan
JAPAN
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01833494     History of Changes
Other Study ID Numbers: PA1302
First Posted: April 17, 2013    Key Record Dates
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018
Last Verified: April 2015
Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Hemodialysis
Hyperphosphatemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases