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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Intervention / Treatment
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* Drug: Daclizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 Dose Daclizbumab<br>daclizumab 1 mg/kg/dose every 14 days for 5 doses | Drug: Daclizumab<br>* daclizumab 1 mg/kg/dose every 14 days for 5 doses<br>|
| Active Comparator: 2 Dose Daclizaumab<br>daclizumab 2 mg/kg/dose every 14 days for 2 doses | Drug: Daclizumab<br>* daclizumab 1 mg/kg/dose every 14 days for 5 doses<br>|
| Active Comparator: Control<br>no antibody induction | Drug: Daclizumab<br>* daclizumab 1 mg/kg/dose every 14 days for 5 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, timing and severity of fungal infections. |  |  | 
| Incidence, timing and severity of malignancies. |  |  | 
| Hospitalizations. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, Pancreas transplant, Daclizumab, Tacrolimus, Mycophenolate mofetil, Steroids, Immunosuppression, Acute allograft rejection