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

Kidney Transplantation Clinical Trial

— OPTIMIZE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161237
• Other study ID #: 506-MA-1001
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2014
• Est. completion date: December 22, 2016

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 22, 2016
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Advagraf®
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimated GFR		at Week-52 after transplantation
Secondary	creatinine clearance		at Week-52 after transplantation
Secondary	serum creatinine level		at Week-52 after transplantation
Secondary	Number of graft survival		at Week-52 after transplantation
Secondary	Subject survival		at Week-52 after transplantation
Secondary	number of biopsy-proven acute rejection		at Week-52 after transplantation
Secondary	Composite of graft loss, subject death and biopsy proven acute rejection		at Week-52 after transplantation
Secondary	Time to the first acute rejection		up to Week-52 after transplantation
Secondary	Time to the first steroid-resistant acute rejection		up to Week-52 after transplantation
Secondary	Severity of biopsy proven acute rejection	Severity is evaluated using Banff '07 Criteria	up to Week-52 after transplantation
Secondary	Safety assessed by the incidence of adverse events, vital signs and lab tests		for 52 weeks after transplantation

External Links

•   Link to results on Astellas Clinical Study Results website