Status:
COMPLETED
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
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Roche Pharma AG
University of Tennessee
Conditions:
Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00363116
Start Date
April 1 1999
End Date
December 1 2004
Last Update
October 25 2013
Active Locations (24)
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1
University of California - Davis
Davis, California, United States, 95616
2
University of California - Los Angeles
Los Angeles, California, United States, 90095
3
Washington Hospital
Washington D.C., District of Columbia, United States, 20010
4
University of Miami
Miami, Florida, United States, 33124