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Trial record 32 of 7870 for:    "Kidney Diseases"

Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02805348
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.

Condition or disease Intervention/treatment
Chronic Kidney Disease Drug: Bixalomer

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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Specified Drug Use-Results Survey in Patients With Pre-dialysis Chronic Kidney Disease
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
Chronic kidney disease
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time.
Drug: Bixalomer
Oral
Other Names:
  • ASP1585
  • AMG223
  • Kiklin
  • ILY101




Primary Outcome Measures :
  1. Change from baseline in the serum concentrations of phosphate [ Time Frame: Baseline and up to Month 12 ]
  2. Change from baseline in the corrected serum concentrations of calcium [ Time Frame: Baseline and up to Month 12 ]
  3. Change from baseline in the serum concentrations of intact parathyroid hormone [ Time Frame: Baseline and up to Month 12 ]
  4. Safety assessed by incidence of adverse events [ Time Frame: Up to Month 12 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time
Criteria

Inclusion Criteria:

  • Patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805348


Locations
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Japan
Site JP00006
Aichi, Japan
Site JP00010
Ehime, Japan
Site JP00012
Fukuoka, Japan
Site JP00004
Gifu, Japan
Site JP00001
Ibaraki, Japan
Site JP00009
Kagawa, Japan
Site JP00003
Kanagawa, Japan
Site JP00011
Kochi, Japan
Site JP00014
Kumamoto, Japan
Site JP00013
Nagasaki, Japan
Site JP00007
Osaka, Japan
Site JP00005
Shizuoka, Japan
Site JP00002
Tochigi, Japan
Site JP00008
Wakayama, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma Inc

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02805348     History of Changes
Other Study ID Numbers: 1585-MA-3052
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Kiklin
Bixalomer
Chronic Kidney Disease

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency