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
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
1 other identifier
interventional
298
2 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 1999
Longer than P75 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 10, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedOctober 25, 2013
October 1, 2013
5.7 years
August 10, 2006
October 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Incidence, timing and severity of fungal infections.
Incidence, timing and severity of malignancies.
Hospitalizations.
Study Arms (3)
5 Dose Daclizbumab
ACTIVE COMPARATORdaclizumab 1 mg/kg/dose every 14 days for 5 doses
2 Dose Daclizaumab
ACTIVE COMPARATORdaclizumab 2 mg/kg/dose every 14 days for 2 doses
Control
ACTIVE COMPARATORno antibody induction
Interventions
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- Roche Pharma AGcollaborator
- University of Tennesseecollaborator
Study Sites (24)
University of California - Davis
Davis, California, 95616, United States
University of California - Los Angeles
Los Angeles, California, 90095, United States
Washington Hospital
Washington D.C., District of Columbia, 20010, United States
University of Miami
Miami, Florida, 33124, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60208, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland
College Park, Maryland, 20742, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Cornell University
Ithaca, New York, 14853, United States
Carolina Medical Center
Charlotte, North Carolina, 28203, United States
Duke University
Durham, North Carolina, 27708, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
University of Texas - Houston
Houston, Texas, 77030, United States
Baylor University
Waco, Texas, 76798, United States
Medical College of Virginia
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Toronto Hospital
Toronto, Ontario, M5G 2C4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Stratta, MD
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
August 10, 2006
First Posted
August 15, 2006
Study Start
April 1, 1999
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
October 25, 2013
Record last verified: 2013-10