- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034747
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients (COSMOS)
A Multicenter, Randomized, Comparison, Open-label, Phase IV Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.
The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Busan, Korea, Republic of
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Chungcheongnam-do, Korea, Republic of
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Daegu, Korea, Republic of
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Gyeonggi-do, Korea, Republic of
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Incheon, Korea, Republic of
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Jeollabuk-do, Korea, Republic of
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Jeollanam-do, Korea, Republic of
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Seoul, Korea, Republic of
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Ulsan, Korea, Republic of
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
- Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
- The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
- GFR≥30 mL/min
Exclusion Criteria:
- Had received an organ transplant other than a kidney
- Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
- Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
- The subject received a kidney transplant from full-HLA identical donor
- Known to have FSGS or MPGN Type II as an underlying disease
- Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
- Has liver cirrhosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Corticosteroid with the 50% reduced dose
oral
|
oral
oral
|
Active Comparator: Corticosteroid with the maintained dose
oral
|
oral
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the GFR before the treatment (baseline) to that on Week 24
Time Frame: Baseline and Week 24
|
Baseline and Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the GFR before the treatment (baseline) to that on Week 12
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24
Time Frame: Baseline, Week 12 and Week 24
|
Baseline, Week 12 and Week 24
|
Incidence of acute rejection
Time Frame: Up to Week 24
|
Up to Week 24
|
Safety assessed by the incidence of adverse events, vital signs and Lab-test
Time Frame: Up to Week 24
|
Up to Week 24
|
Physical examinations including cyclosporine related cosmetic side effect
Time Frame: Up to Week 24
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Up to Week 24
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ADV-KT-13-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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