Status:
UNKNOWN
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
Lead Sponsor:
Nantes University Hospital
Conditions:
Pancreas Transplantation
Kidney Transplantation
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Experience with tacrolimus in pancreas transplantation has become a standard for immunosuppression in almost all pancreas centers over the world. Several centers have shown very good results in simult...
Detailed Description
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) plu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00693446
Start Date
April 1 2004
End Date
April 1 2017
Last Update
May 12 2015
Active Locations (1)
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1
CHU de Nantes
Nantes, Nantes, France