Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

January 26, 2017 updated by: Astellas Pharma Inc

Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphataemia Receiving Hemodialysis

The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Study Type

Observational

Enrollment (Actual)

1078

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
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kantou, Japan
      • Kinki, Japan
      • Kyusyu, Japan
      • Shikoku, Japan
      • Touhoku, 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Description

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Kiklin group
Drug: Kiklin capsules
oral
Other Names:
  • ILY101
  • AMG223
  • ASP1585
  • bixalomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by the incidence of adverse events, physical exam and lab-tests
Time Frame: for one year
for one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum calcium level
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration
Serum phosphate level
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration
Intact PTH (parathyroid hormone) level
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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

January 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIK001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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