Clinical trial NCT02034747: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Keywords: Immunosuppressive regimen
Advagraf
kidney transplant
Corticosteroid
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the GFR before the treatment (baseline) to that on Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in the GFR before the treatment (baseline) to that on Week 12
timeFrame: Baseline and Week 12
measure: Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Incidence of acute rejection
timeFrame: Up to Week 24
measure: Safety assessed by the incidence of adverse events, vital signs and Lab-test
timeFrame: Up to Week 24
measure: Physical examinations including cyclosporine related cosmetic side effect
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Chungcheongnam-do
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Jeollanam-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References: