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

Kidney Transplant Clinical Trial

— COSMOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034747
• Other study ID #: ADV-KT-13-01
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2013
• Est. completion date: November 7, 2015

Study information

• Verified date: July 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 7, 2015
• Est. primary completion date: November 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Advagraf
oral
• Corticosteroid
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the GFR before the treatment (baseline) to that on Week 24		Baseline and Week 24
Secondary	Change in the GFR before the treatment (baseline) to that on Week 12		Baseline and Week 12
Secondary	Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24		Baseline, Week 12 and Week 24
Secondary	Incidence of acute rejection		Up to Week 24
Secondary	Safety assessed by the incidence of adverse events, vital signs and Lab-test		Up to Week 24
Secondary	Physical examinations including cyclosporine related cosmetic side effect		Up to Week 24

External Links

•   Link to results on the Astellas Clinical Study Results website