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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)

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ClinicalTrials.gov Identifier: NCT02034747
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Study Description
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Brief Summary:
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Advagraf Drug: Corticosteroid Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 21, 2013
Actual Primary Completion Date : November 7, 2015
Actual Study Completion Date : November 7, 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Corticosteroid with the 50% reduced dose
oral
 Drug: Advagraf
oral

Drug: Corticosteroid
oral
Active Comparator: Corticosteroid with the maintained dose
oral
 Drug: Advagraf
oral

Drug: Corticosteroid
oral


Outcome Measures
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Primary Outcome Measures :
  1. Change in the GFR before the treatment (baseline) to that on Week 24 [ Time Frame: Baseline and Week 24 ]

Secondary Outcome Measures :
  1. Change in the GFR before the treatment (baseline) to that on Week 12 [ Time Frame: Baseline and Week 12 ]
  2. Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24 [ Time Frame: Baseline, Week 12 and Week 24 ]
  3. Incidence of acute rejection [ Time Frame: Up to Week 24 ]
  4. Safety assessed by the incidence of adverse events, vital signs and Lab-test [ Time Frame: Up to Week 24 ]
  5. Physical examinations including cyclosporine related cosmetic side effect [ Time Frame: Up to Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02034747


Locations
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Korea, Republic of
Busan, Korea, Republic of
Chungcheongnam-do, Korea, Republic of
Daegu, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Incheon, Korea, Republic of
Jeollabuk-do, Korea, Republic of
Jeollanam-do, Korea, Republic of
Seoul, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
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Principal Investigator: Medical Director Astellas Pharma Inc
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT02034747    
Other Study ID Numbers: ADV-KT-13-01
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Immunosuppressive regimen
Advagraf
kidney transplant
Corticosteroid