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An Open-Label, Comparative, Randomized, Prospective 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


Phase 4
18 Years
60 Years
Open (Enrolling)
Both
Pancreas Transplantation, Kidney Transplantation

Thank you

Trial Information

An Open-Label, Comparative, Randomized, Prospective 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


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 In both regimens corticosteroids (CS) will be withdrawn three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 after transplantation at 12 months and for a total
period of 5 years of follow-up.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Kidney graft and pancreas graft survivals at month 12.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Diego CANTAROVICH, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD/04/2-D

NCT ID:

NCT00693446

Start Date:

April 2004

Completion Date:

April 2017

Related Keywords:

  • Pancreas Transplantation
  • Kidney Transplantation
  • Pancreas-kidney allograft
  • tacrolimus
  • sirolimus
  • Pancreas-kidney allograft recipients

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