Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Kidney TransplantationKidney Disease
Interventions
DRUG

Alemtuzumab

30mg intravenous infusion on days 0 (transplant), 1, and 2

DRUG

Sirolimus

2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year

DRUG

Tacrolimus

2mg orally twice daily, on days 1-60

PROCEDURE

Kidney transplant

Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)

DRUG

Methylprednisolone (or equivalent)

250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab

DRUG

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

DRUG

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

DRUG

Trimethoprim (TMP)/Sulfa (Bactrim, Septra)

1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.

DRUG

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

DRUG

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.

DRUG

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

DRUG

Clotrimazole

10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)

DRUG

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)

Trial Locations (1)

53792-1735

University of Wisconsin - Department of Medicine, Madison

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

lead

University of Wisconsin, Madison

OTHER

NCT00078559 - Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults | Biotech Hunter | Biotech Hunter