Overview

This trial is active, not recruiting.

Condition kidney transplantation
Treatments advagraf, simulect, cellcept, corticosteroids, ramipril, irbesartan
Phase phase 3
Sponsor Astellas Pharma Inc
Collaborator Astellas Pharma Canada, Inc.
Start date June 2009
End date June 2015
Trial size 281 participants
Trial identifier NCT00933231, FKC-014

Summary

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
advagraf Tacrolimus XL
Standard dose, Oral
simulect Basiliximab
IV
cellcept MMF
Oral
corticosteroids Methylprednisolone
IV and Oral
ramipril ACEi
Oral
irbesartan ARB
Oral
(Active Comparator)
advagraf Tacrolimus XL
Standard dose, Oral
simulect Basiliximab
IV
cellcept MMF
Oral
corticosteroids Methylprednisolone
IV and Oral
(Experimental)
advagraf Tacrolimus XL
Low dose, Oral
simulect Basiliximab
IV
cellcept MMF
Oral
corticosteroids Methylprednisolone
IV and Oral
ramipril ACEi
Oral
irbesartan ARB
Oral
(Experimental)
advagraf Tacrolimus XL
Low dose, Oral
simulect Basiliximab
IV
cellcept MMF
Oral
corticosteroids Methylprednisolone
IV and Oral

Primary Outcomes

Measure
The incidence of allograft interstitial fibrosis and tubular atrophy (IF/TA) as assessed at a central pathology lab
time frame: 6 months

Secondary Outcomes

Measure
The incidence of allograft IF/TA between 6 and 24 months as assessed at a central pathology lab
time frame: 6 and 24 months
Renal function will be evaluated by estimation of glomerular filtration rate (GFR), serum creatinine, and urine protein:creatinine ratio
time frame: 1, 3, 6, 12 months and annually thereafter (Up to 5 years)
Blood pressure and the use of antihypertensive agents will be evaluated
time frame: 1, 3, 6, 12 months and annually thereafter

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject is the recipient of a first or second deceased or living donor renal transplant (one kidney only) - Subject must have at least one HLA-mismatch with the donor. HLA identical donor-recipient pairs are not eligible - Subject understands either English or French - If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods Exclusion Criteria: - Presence of donor specific antibody - Subject who is currently participating in a study with investigational drug, or who has received investigational drug within three months prior to randomization. Observational studies are acceptable - Subject who has lost a previous graft for immunological reasons less than one year from transplant - Subject is pregnant or breastfeeding - Subject receives a kidney lacking pre-implantation biopsy - Subject has significant disease (e.g. malignancy or uncontrolled infection) or disability (e.g. cognitive defect) which prevents understanding of, or adherence to the protocol - Subject who in the opinion of the Investigator, require ACEi/ARB therapy post-transplant for any indication - Subject who requires induction with Thymoglobulin, Campath, antithymocyte globulin (ATG), antilymphocyte globulin (ALG) or any biological induction agent other than basiliximab. Unplanned post-transplant use of these prohibited drugs for clinical indications post-transplant is allowed - Subject has plans to become pregnant within 2 years post-transplant - Subject who has a positive T-cell or B-cell crossmatch. Subjects with a weakly positive B-cell cross-match that tests negative following DTT reduction are acceptable - Subject who has a requirement for maintenance immunosuppressant therapy with the exception of low dose steroid or mycophenolate mofetil (MMF). A subject who is on low dose tacrolimus maintenance therapy will be eligible provided the tacrolimus is withheld at least 1 week prior to transplant

Additional Information

Official title A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response
Principal investigator Principal Investigator
Description The study will consist of the following 4 treatment groups.: 1. Standard dose Advagraf with angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB) antihypertensive therapy 2. Standard dose Advagraf without ACEi/ARB antihypertensive therapy 3. Low dose Advagraf with ACEi/ARB antihypertensive therapy 4. Low dose Advagraf without ACEi/ARB antihypertensive therapy
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.