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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


Phase 4
18 Years
65 Years
Not Enrolling
Both
Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Thank you

Trial Information

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


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.


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 BsAg positive

- Investigational drug within 30 days prior to transplant surgery

- Anti-T cell therapy within 30 days prior to transplant surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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.

Principal Investigator

Robert J Stratta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tennessee

Authority:

United States: Food and Drug Administration

Study ID:

ZEN049

NCT ID:

NCT00363116

Start Date:

Completion Date:

Related Keywords:

  • Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
  • Kidney transplant
  • Pancreas transplant
  • Daclizumab
  • Tacrolimus
  • Mycophenolate mofetil
  • Steroids
  • Immunosuppression
  • Acute allograft rejection

Name

Location
University of Iowa Iowa City, Iowa  52242
Medical University of South Carolina Charleston, South Carolina  29425-0721
Medical College of Wisconsin Milwaukee, Wisconsin  53226
University of Minnesota Minneapolis, Minnesota  55455
University of Washington Seattle, Washington  98195
Duke University Durham, North Carolina  27710
Baylor University Waco, Texas  
Medical College of Virginia Richmond, Virginia  23298-0341
Northwestern University Chicago, Illinois  60611
Emory University Atlanta, Georgia  30322
Ohio State University Columbus, Ohio  43210
University of Maryland Baltimore, Maryland  21201
University of Chicago Chicago, Illinois  60637
University of Miami Miami, Florida  33136
Carolina Medical Center Charlotte, North Carolina  28203
Oregon Health Science University Portland, Oregon  97239
University of Wisconsin Madison,, Wisconsin  53792-5666
Cornell University New York, New York  10021
University of Tennessee Memphis, Tennessee  38163
University of California - Los Angeles Los Angeles, California  90095
University of California - Davis Davis, California  95616
Washington Hospital Washington, District of Columbia  20010
University of Texas - Houston Houston, Texas  77030