Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

• Status: Completed
• Trial end date: 2018-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Basiliximab; Enzyme Inhibitors; Irbesartan; Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Ramipril; Tacrolimus

Criteria

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