A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Cincinnati
With
Roche Pharma AG
University of Tennessee
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.
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
You may not be if
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
Clareo Health | A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
