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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. )

Tracking Information
First Submitted Date  ICMJE January 10, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date November 30, 2018
Actual Study Start Date  ICMJE November 21, 2013
Actual Primary Completion Date November 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Change in the GFR before the treatment (baseline) to that on Week 24 [ Time Frame: Baseline and Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Change in the GFR before the treatment (baseline) to that on Week 12 [ Time Frame: 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 ]
  • Incidence of acute rejection [ Time Frame: Up to Week 24 ]
  • Safety assessed by the incidence of adverse events, vital signs and Lab-test [ Time Frame: Up to Week 24 ]
  • Physical examinations including cyclosporine related cosmetic side effect [ Time Frame: Up to Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 ®.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplant
Intervention  ICMJE
  • Drug: Advagraf
    oral
  • Drug: Corticosteroid
    oral
Study Arms  ICMJE
  • Experimental: Corticosteroid with the 50% reduced dose
    oral
    Interventions:
    • Drug: Advagraf
    • Drug: Corticosteroid
  • Active Comparator: Corticosteroid with the maintained dose
    oral
    Interventions:
    • Drug: Advagraf
    • Drug: Corticosteroid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2015
Actual Primary Completion Date November 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034747
Other Study ID Numbers  ICMJE ADV-KT-13-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
Study Sponsor  ICMJE Astellas Pharma Korea, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP