10
Participants
Start Date
November 30, 2003
Primary Completion Date
February 28, 2010
Study Completion Date
February 28, 2010
Alemtuzumab
30mg intravenous infusion on days 0 (transplant), 1, and 2
Sirolimus
2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
Tacrolimus
2mg orally twice daily, on days 1-60
Kidney transplant
Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
Methylprednisolone (or equivalent)
250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
Acetaminophen
650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Diphenhydramine
25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
Trimethoprim (TMP)/Sulfa (Bactrim, Septra)
1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
Valgancyclovir
Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
Acyclovir
400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
Pentamidine
300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
Clotrimazole
10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
Nystatin
500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)
University of Wisconsin - Department of Medicine, Madison
Immune Tolerance Network (ITN)
NETWORK
University of Wisconsin, Madison
OTHER