Clinical trial NCT02161237: Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
Official title: A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Acute rejection
Advagraf
Renal function
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: estimated GFR
timeFrame: at Week-52 after transplantation
Secondary outcomes:
measure: creatinine clearance
timeFrame: at Week-52 after transplantation
measure: serum creatinine level
timeFrame: at Week-52 after transplantation
measure: Number of graft survival
timeFrame: at Week-52 after transplantation
measure: Subject survival
timeFrame: at Week-52 after transplantation
measure: number of biopsy-proven acute rejection
timeFrame: at Week-52 after transplantation
measure: Composite of graft loss, subject death and biopsy proven acute rejection
timeFrame: at Week-52 after transplantation
measure: Time to the first acute rejection
timeFrame: up to Week-52 after transplantation
measure: Time to the first steroid-resistant acute rejection
timeFrame: up to Week-52 after transplantation
measure: Severity of biopsy proven acute rejection
timeFrame: up to Week-52 after transplantation
measure: Safety assessed by the incidence of adverse events, vital signs and lab tests
timeFrame: for 52 weeks after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: