De novo simultaneous pancreas and kidney transplant recipients.
Conditions
Interventions
Randomization for the type of induction therapy:
A) Zenapax® (5 gifts of 1 mg/kg, with a maximum of 100 mg per dose, diluted in 50 mL of sterile 0.9% sodium chloride solution). The first dose will b
Sponsors
Roche, Fresenius
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 1 diabetics (C-peptide negative) with (pre)terminal or end-stage renal failure scheduled to receive a simultaneous pancreas kidney cadaveric transplantation, with either bladder or enteric drainage; 2. Patients scheduled to receive mycophenolate mofetil (CellCept), cyclosporin (Neoral) and corticosteriods as basis immunusuppression; 3. Male and female patients > 18 years old; 4. Patients capable of understanding the purpose and risks of the study and from whom informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Pancreas after kidney transplant (PAK), pancreas transplant alone (PTA), segmental pancreatic transplant; 2. Duct occlusion technique; 3. Induction therapy with OKT3 planned; 4. Pregnant or nursing women and women unwilling to use adequate contraception during, and three months following the conclusion of treatment with MMF; 5. Patients scheduled to receive FK 506 (tacrolimus) or Azathioprine as basis immunusuppression; 6. Patients with severe gastrointestinal disorders, that interfere with their ability to receive or absorb oral medication and patients with severe diarrhea; 7. Patients with active peptic ulcer disease; 8. Patients or their donors with serologic evidence of HIV, HCV or HBsAg in the past; 9. Patients with malignancies (current or history within last 5 years) except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully; 10. Patients with systemic infection requiring therapy at the time of entry to the study; 11. Patients being treated with unlicenced, investigational drugs or other prohibited medication; 12. Patients with any form of substance abuse or psychiatric disorder which in the opinion of the investigator might invalidate patients communication with the clinician; 13. Patients with known hypersensitivity to Daclizumab or to any of the components of this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prevention of biopsy proven early graft rejection and steroid-resistant rejection episodes in the first 6 months after simultaneous pancreas kidney transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrence of autoimmune disease parameters; 2. Time to first rejection, time after last prophylactic dose and number of steroid-resistant rejection episodes at 3 and 6 months after transplantation; 3. Graft and patient survival; 4. Immunophenotyping peripheral blood lymphocytes (CD3, CD4, CD8 and CD25 respectively); 5. Adverse events and opportunistic infections; 6. After the first year patient and graft survival and the occurrence of graft dysfunction will be monitored and documented according to local practice. | — |
Contacts
Public ContactJ.W. Fijter, de
Leiden University Medical Center (LUMC), Department of Nephrology, C3-P22, P.O. Box 9600
Outcome results
None listed