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

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Treatments: Drug: Daclizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00363116

ZEN049

Details and patient eligibility

About

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

Full 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.

Enrollment: 298 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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298 participants in 3 patient groups

5 Dose Daclizbumab

Active Comparator group

Description:

daclizumab 1 mg/kg/dose every 14 days for 5 doses

Treatment:

Drug: Daclizumab

2 Dose Daclizaumab

Active Comparator group

Description:

daclizumab 2 mg/kg/dose every 14 days for 2 doses

Treatment:

Drug: Daclizumab

Control

Active Comparator group

Description:

no antibody induction

Treatment:

Drug: Daclizumab