Overview

Improved Induction and Maintenance Immunosuppression in Kidney Transplantation

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; the other half receive the standard treatment. The two potential improvements are: 1. Administering the immunosuppression induction agent rATG ("rabbit anti-thymocyte globulin") in a single dose at the time of transplantation, instead of in the usual series of 4 smaller doses over 6 days. 2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by replacing the drug tacrolimus with mycophenolate mofetil (MMF). The two interventions, spaced sequentially six months apart, enable independent analysis of the two treatments so long as it can be shown that there is no synergistic interaction between them.
Phase:
Phase 4
Details
Lead Sponsor:
R. Brian Stevens, MD
Collaborator:
Genzyme, a Sanofi Company
Treatments:
Antilymphocyte Serum
Calcineurin Inhibitors
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus
Thymoglobulin