PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia

November 27, 2017 updated by: Kissei Pharmaceutical Co., Ltd.
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

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
        • 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:

  • 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: PA21 750 mg/day
Drug: PA21
Experimental: PA21 1500 mg/day
Drug: PA21
Experimental: PA21 2250 mg/day
Drug: PA21
Experimental: PA21 3000 mg/day
Drug: PA21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.
Time Frame: 6 weeks
Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Calcium Concentrations.
Time Frame: 6 weeks
6 weeks
Change From Baseline in Serum Intact-PTH Concentrations.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Kissei Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Tatsuro Takei, Clinical Development Department, 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)

January 11, 2012

Primary Completion (Actual)

July 3, 2012

Study Completion (Actual)

July 3, 2012

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA1201

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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