Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis
1 other identifier
observational
123
1 country
8
Brief Summary
To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2013
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2013
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 22, 2024
March 1, 2020
6.8 years
July 17, 2013
October 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests
Baseline and 1, 2, 3, 6, 12 months after administration
Secondary Outcomes (4)
Serum phosphorous levels
Baseline and 1, 2, 3, 6, 12 months after administration
Serum albumin level
Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level
Baseline and 1, 2, 3, 6, 12 months after administration
Serum intact PTH (parathyroid hormone) level
Baseline and 1, 2, 3, 6, 12 months after administration
Study Arms (1)
Kiklin group
Oral
Interventions
Eligibility Criteria
Patients with Chronic renal failure with Hyperphosphatemia receiving Peritoneal dialysis
You may qualify if:
- Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kanto, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 19, 2013
Study Start
March 19, 2013
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
October 22, 2024
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
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/.