Acute Rejection, Renal Transplantation
Conditions
Brief summary
The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).
Interventions
DRUGCampath-1H, rituximab, myfortic
Campath-1H 30mg IV x 2 doses, rituximab 375mg/m2 IV x 1 dose, myfortic 720mg bid, cyclosporine po bid (target trough 200ng/ml) x 10-20 days
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recipient of cadaver or non HLA identical living donor transplantation (tx), Re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p) * Females of CBP must have neg preg test at the time of study enrollment (SOC) & agree to practice birth control for duration of the study, or for 6 weeks after the last dose of Myfortic
Exclusion criteria
* Subjects who are pregnant or nursing. * Current malignancy or a malignancy in the past 5 years, except for excised skin CA (BCC or SC) * Multi-organ tx, ABO incompatible and + CM * Subjects with a current PRA \>50% within the past 30 days pre tx * Subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis B (surface antigen +) or +HCV. * Exclude for subjects who have received an investigational drug within 4 weeks of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| hypertension | 2 years |
| drug side effects | 2 years |
Countries
United States
Outcome results
None listed