A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

March 2, 2018 updated by: Kissei Pharmaceutical Co., Ltd.
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PA21
Drug: PA21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
TSAT at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
Hb Concentrations at End of Treatment (Actual Measured Value)
Time Frame: 12 weeks
12 weeks
Constipation Condition
Time Frame: 12 weeks
12 weeks
Satisfaction With Bowel Movement
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kissei Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 3, 2013

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA1304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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