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

NCT ID: NCT02034747

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-21
• Study Completion Date: 2015-11-07

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.

Conditions

Kidney Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Corticosteroid with the 50% reduced dose

oral

Group Type: EXPERIMENTAL

Advagraf

Intervention Type: DRUG

oral

Corticosteroid

Intervention Type: DRUG

oral

Corticosteroid with the maintained dose

oral

Group Type: ACTIVE_COMPARATOR

Advagraf

Intervention Type: DRUG

oral

Corticosteroid

Intervention Type: DRUG

oral

Interventions

Advagraf

oral

Intervention Type: DRUG

Corticosteroid

oral

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: PRINCIPAL_INVESTIGATOR

Astellas Pharma Inc

Locations

Busan, , South Korea

Chungcheongnam-do, , South Korea

Daegu, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Jeollabuk-do, , South Korea

Jeollanam-do, , South Korea

Seoul, , South Korea

Ulsan, , South Korea

Countries

South Korea

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=197

Link to results on the Astellas Clinical Study Results website

Other Identifiers

ADV-KT-13-01

Identifier Type: -

Identifier Source: org_study_id