A Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids

Launched by NANTES UNIVERSITY HOSPITAL · Jun 6, 2008

Keywords

ClinConnect Summary

The main objective is to compare renal and pancreas graft survivals at 12 months after simultaneous pancreas-kidney transplantation in patients receiving either a regimen combining sirolimus (SRL) plus mycophenolate mofetil (MMF) following an antibody induction (rATG) or a regimen combining tacrolimus (TAC) plus mycophenolate mofetil following an antibody induction (rATG). In both regimens corticosteroids (CS) will be withdrawn three months after transplantation.

In addition, the two treatment groups will be compared for acute rejection, renal and pancreas functions and patient survival af...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Recipient age ≥ 18 and ≤ 60 years.
• • Patients receiving a first cadaveric simultaneous pancreas-kidney transplant for insulin-dependent diabetes associated with end-stage renal disease.
• • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation.
• • Signed and dated informed consent.
• Exclusion Criteria:
• • Donor age ≤ 15 years and ≥ 60 years.
• • Evidence of active systemic or localized major infection.
• • Evidence of infiltrate, cavitation, or consolidation on chest x-ray.
• • Use of any investigational drug or treatment (in particular immuno-suppressive drugs) up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase.
• • History of malignancy (with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence within 5 years of enrolment into the study).
• • Graft from a living donor.
• • Double renal graft.
• • Pregnancy.
• • Known hypersensitivity to sirolimus and its derivatives or to tacrolimus.
• • Known hypersensitivity to rabbit's proteins.
• • Multiple organ transplants or recipients of previously transplanted organs other than kidney.
• • Treatment with cisapride (PrépulsidÒ), pimozide (OrapÒ), ketoconazole (NizoralÒ), fluconazole (TriflucanÒ) or millepertuis (ProcalmilÒ, Arkogélules MillepertuisÒ), that is not discontinued within 24 hours prior to transplant.
• • Total white blood cell count ≤ 2 x 109/L or platelet count ≤ 70.000/mm3 at baseline.
• • Patients with evidence of active histological or biological hepatic disease during the six months period before the transplantation.
• • HIV positive recipients.
• • Non-heart beating donor.