Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients Clinical Trial
Official title:
An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
| Verified date | October 2013 |
| Source | University of Cincinnati |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
| Status | Completed |
| Enrollment | 298 |
| Est. completion date | December 2004 |
| Est. primary completion date | December 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Hospital | Toronto | Ontario |
| United States | Emory University | Atlanta | Georgia |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Carolina Medical Center | Charlotte | North Carolina |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | University of Maryland | College Park | Maryland |
| United States | Ohio State University | Columbus | Ohio |
| United States | University of California - Davis | Davis | California |
| United States | Duke University | Durham | North Carolina |
| United States | University of Texas - Houston | Houston | Texas |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Cornell University | Ithaca | New York |
| United States | University of California - Los Angeles | Los Angeles | California |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | University of Tennessee | Memphis | Tennessee |
| United States | University of Miami | Miami | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Oregon Health Science University | Portland | Oregon |
| United States | Medical College of Virginia | Richmond | Virginia |
| United States | University of Washington | Seattle | Washington |
| United States | Baylor University | Waco | Texas |
| United States | Washington Hospital | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cincinnati | Roche Pharma AG, University of Tennessee |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | ||
| Secondary | Incidence, timing and severity of fungal infections. | No | ||
| Secondary | Incidence, timing and severity of malignancies. | No | ||
| Secondary | Hospitalizations. | No |