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

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Advagraf®

• Registration Number: NCT02161237
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-11
• Study Start: 2014-06-26
• Primary Completion: 2016-12-22
• Study Completion: 2016-12-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose group	Advagraf®	Oral
optimized dose group	Advagraf®	Oral

Primary Outcome Measures

Name	Time	Method
estimated GFR	at Week-52 after transplantation

Secondary Outcome Measures

Name	Time	Method
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
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
number of biopsy-proven acute rejection	at 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	Severity is evaluated using Banff '07 Criteria
Safety assessed by the incidence of adverse events, vital signs and lab tests	for 52 weeks after transplantation