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
- Conditions
- Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
- Interventions
- Registration Number
- NCT00363116
- Lead Sponsor
- University of Cincinnati
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 298
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5 Dose Daclizbumab Daclizumab daclizumab 1 mg/kg/dose every 14 days for 5 doses 2 Dose Daclizaumab Daclizumab daclizumab 2 mg/kg/dose every 14 days for 2 doses Control Daclizumab no antibody induction
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hospitalizations. Incidence, timing and severity of fungal infections. Incidence, timing and severity of malignancies.
Trial Locations
- Locations (24)
University of California - Davis
🇺🇸Davis, California, United States
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Washington Hospital
🇺🇸Washington, District of Columbia, United States
University of Miami
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland
🇺🇸College Park, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
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