Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®
Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of
Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25
humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks
later. (controls) Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of
Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at
0.3 mg/kg within 24 hours. No further antibody therapy will be used.
In both groups, Prograf® maintenance therapy will be rapidly initiated (vide-infra) with a
targeting dosage to 12 hour trough levels of 4 to 8 ng/ml.
In Group I, maintenance dosing Myfortic® will be targeted to 720 mg twice daily. In Group
II, maintenance doses of Myfortic® will be targeted to 360 mg twice daily.
Steroids are to be given equivalently in both groups only during the first week
postoperatively. The regimen consists of 500 mg/day of Solumedrol intravenously for 3
postoperative days followed by daily oral methylprednisolone or IV Solumedrol at 1 mg/kg per
day, decreasing to 0.5 mg/kg per day during the remainder of the week primarily to avoid
hypersensitivity reactions to the induction antibodies. No further steroid use is planned.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence of Acute Rejection at one year post-transplant
at one year post-transplant
United States: Institutional Review Board
|University Of Miami Miller School Of Medicine||Miami, Florida 33010|