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COSMOS: 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

Sponsor
Astellas Pharma Korea, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02034747
Collaborator
(none)
150
Enrollment
9
Locations
2
Arms
23.5
Actual Duration (Months)
16.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Nov 21, 2013
Actual Primary Completion Date :
Nov 7, 2015
Actual Study Completion Date :
Nov 7, 2015

Arms and Interventions

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

Primary Outcome Measures

  1. Change in the GFR before the treatment (baseline) to that on Week 24 [Baseline and Week 24]

Secondary Outcome Measures

  1. Change in the GFR before the treatment (baseline) to that on Week 12 [Baseline and Week 12]

  2. Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24 [Baseline, Week 12 and Week 24]

  3. Incidence of acute rejection [Up to Week 24]

  4. Safety assessed by the incidence of adverse events, vital signs and Lab-test [Up to Week 24]

  5. Physical examinations including cyclosporine related cosmetic side effect [Up to Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Busan Korea, Republic of
2 Chungcheongnam-do Korea, Republic of
3 Daegu Korea, Republic of
4 Gyeonggi-do Korea, Republic of
5 Incheon Korea, Republic of
6 Jeollabuk-do Korea, Republic of
7 Jeollanam-do Korea, Republic of
8 Seoul Korea, Republic of
9 Ulsan Korea, Republic of

Sponsors and Collaborators

  • Astellas Pharma Korea, Inc.

Investigators

  • Principal Investigator: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier:
NCT02034747
Other Study ID Numbers:
  • ADV-KT-13-01
First Posted:
Jan 13, 2014
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Astellas Pharma Korea, Inc.
Immunosuppressive regimen
Advagraf
kidney transplant
Corticosteroid

Study Results

No Results Posted as of Jul 27, 2022