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

Stopped early · Phase 1/Phase 2

Conditions studied: Kidney Transplantation, Chronic Kidney Failure

In brief

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.

Key facts

Study ID

NCT00472082

Run by

Emory University

People needed

5

Starts

2007-05-01

Expected to finish

2009-04-01

Last updated by the study team

2014-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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