Clinical trial NCT00363116: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Keywords: Kidney transplant
Pancreas transplant
Daclizumab
Tacrolimus
Mycophenolate mofetil
Steroids
Immunosuppression
Acute allograft rejection
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: University of Tennessee
First posted: 2006-08-15
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
measure: Incidence, timing and severity of fungal infections.
measure: Incidence, timing and severity of malignancies.
measure: Hospitalizations.
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California - Davis
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Washington
country: United States
facility: Washington Hospital
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Ithaca
country: United States
facility: Cornell University
state: New York
city: Charlotte
country: United States
facility: Carolina Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Waco
country: United States
facility: Baylor University
state: Texas
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto Hospital
state: Ontario
Study officials:
affiliation: University of Tennessee
name: Robert J Stratta, MD
role: PRINCIPAL_INVESTIGATOR
References: