A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.

Astellas Pharma Inc0 sites73 target enrollmentJune 26, 2014

ConditionsKidney Transplantation

InterventionsAdvagraf®

DrugsAdvagraf®

Overview

Phase: Phase 4
Intervention: Advagraf®
Conditions: Kidney Transplantation
Sponsor: Astellas Pharma Inc
Enrollment: 73
Primary Endpoint: estimated GFR
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.

Registry

clinicaltrials.gov

Start Date

June 26, 2014

End Date

December 22, 2016

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
•Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
•Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study

Exclusion Criteria

•Receiving or having previously received an organ transplant other than a kidney
•Cold ischemia time of the donor kidney \> 24 hours
•Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
•Significant liver disease
•Receiving a graft from a hepatitis C or B positive donor
•Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
•Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
•Subject or donor known to be HIV positive
•Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
•Subject has malignant tumor

Arms & Interventions

standard dose group

Oral

Intervention: Advagraf®

optimized dose group

Oral

Intervention: Advagraf®

Outcomes

Primary Outcomes

estimated GFR

Time Frame: at Week-52 after transplantation

Secondary Outcomes

creatinine clearance(at Week-52 after transplantation)
serum creatinine level(at Week-52 after transplantation)
Number of graft survival(at Week-52 after transplantation)
Subject survival(at Week-52 after transplantation)
number of biopsy-proven acute rejection(at Week-52 after transplantation)
Composite of graft loss, subject death and biopsy proven acute rejection(at Week-52 after transplantation)
Time to the first acute rejection(up to Week-52 after transplantation)
Time to the first steroid-resistant acute rejection(up to Week-52 after transplantation)
Severity of biopsy proven acute rejection(up to Week-52 after transplantation)
Safety assessed by the incidence of adverse events, vital signs and lab tests(for 52 weeks after transplantation)