Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Conditions
Keywords
Kidney transplant, Pancreas transplant, Daclizumab, Tacrolimus, Mycophenolate mofetil, Steroids, Immunosuppression, Acute allograft rejection
Brief summary
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
Detailed description
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.
Interventions
DRUGDaclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Sponsors
Roche Pharma AG
University of Tennessee
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Simultaneous kidney/pancreas transplant recipients * Insulin dependent Type 1 or 2 diabetes pretransplant * Recipient age 18-65 years * Donor age 5-65 years * Women must have negative serum pregnancy test and practice birth control for study duration * Negative T-cell crossmatch * Parent (or guardian) is able to understand the consent form and give written informed consent
Exclusion criteria
* Prior treatment with daclizumab * Known sensitivity or contraindication to tacrolimus, MMF, or steroids * Patient with significant or active infection * Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum * Patients whose life expectancy is severely limited by diseases other than renal disease * Ongoing substance abuse, drug or alcohol * Major ongoing psychiatric illness or recent history of noncompliance * Insufficient cardiovascular reserve * Malignancy within last 5 years, excluding nonmelanoma skin cancers * Serologic evidence of infection with HIV or Hepatitis B surface antigen positive * Investigational drug within 30 days prior to transplant surgery * Anti-T cell therapy within 30 days prior to transplant surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, timing and severity of fungal infections. | — |
| Incidence, timing and severity of malignancies. | — |
| Hospitalizations. | — |
Countries
Canada, United States
Outcome results
None listed