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)

July 26, 2022 updated by: Astellas Pharma Korea, Inc.

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

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 ®.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2013

Primary Completion (Actual)

November 7, 2015

Study Completion (Actual)

November 7, 2015

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

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)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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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