A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

March 2, 2018 updated by: Kissei Pharmaceutical Co., Ltd.
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PA21
Drug: PA21
Active Comparator: Sevelamer hydrochloride
Drug: Sevelamer hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
Time Frame: 12 weeks
Covariate: Serum phosphorus concentrations at baseline.
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

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 23, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 10, 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

  • PA1301

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.

Clinical Trials on Hemodialysis

Clinical Trials on Sevelamer hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe