Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation (OPTIMIZE)

Astellas

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: Advagraf®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02161237

506-MA-1001

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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
Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
Subject with a high immunological risk