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

October 19, 2024 updated by: Astellas Pharma Inc
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

123

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
      • Kansai, Japan
      • Kanto, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Tohoku, 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

Sampling Method

Non-Probability Sample

Study Population

Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis

Description

Inclusion Criteria:

  • Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

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
Oral
Drug: bixalomer
Oral
Other Names:
  • Kiklin
  • ILY101
  • AMG223
  • ASP1585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum phosphorous levels
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin level
Time Frame: Baseline and 1, 2, 3, 6, 12 months after administration
Baseline and 1, 2, 3, 6, 12 months after administration
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 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

Investigators

  • Study Director: Use Central Contact, 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 (Actual)

March 19, 2013

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimated)

July 19, 2013

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 19, 2024

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIK002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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