Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The toxicity of calcineurin inhibitors(CNI)is a major factor limiting the success of renal transplantation. This protocol aims to replace the calcineurin inhibitor, tacrolimus, with efalizumab early after transplantation in patients with mild impairment of renal function in order to minimize the toxicities of CNI.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Tacrolimus

Criteria

Inclusion Criteria:

• Primary renal transplant recipients

• recipients of deceased donor or living donor transplant

• Age 18-65 years (inclusive)

• Male or female

• Within 3-9 month window post-transplantation

• No episodes of acute rejection prior to enrollment

• Mild impairment of renal function as defined by a calculated CrCl of 35-50 ml/min/m2

Exclusion Criteria:

• Subjects with any prior solid organ transplant (including kidney)

• Subjects with a history of panel-reactive antibodies greater than 20% or the development of new anti-HLA antibodies after transplantation and prior to enrollment

• Subjects the Investigator deems to be at a relatively higher risk for acute rejection

• HLA-identical living donor pairs

• Evidence of infection with Hepatitis C (antibody positive or PCR positive), Hepatitis B ( surface antigen positive), HIV

• Subjects with BK or CMV viremia prior to enrollment

• Multiple organ transplant recipients

• Subjects with underlying renal disease of focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, hemolytic-uremic syndrome/thrombocytopenic purpura syndrome (due to risk of rapid disease recurrence in the allograft

• EBV negative recipients

• Women who are pregnant or nursing

• Women of child bearing age unwilling or unable to use an acceptable method to avoid pregnancy for the duration of the study and up to 8 weeks after last injection

• Patients not able to tolerate a dose of at least 500 mg of mycophenolate mofetil twice daily

• Allergy to Iodine