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Sponsored by: |
Nantes University Hospital |
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Information provided by: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT00693446 |
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 simultaneous pancreas-kidney (SPK) transplant recipients receiving antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin inhibitor and mycophenolate mofetil with or without corticosteroids.
The use of sirolimus in SPK transplant patients has for the moment only been studied, with good results, in association with tacrolimus or cyclospsorine (CsA). In renal transplantation, there is also evidence that sirolimus (Rapamune) is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA, effective as base therapy in the post-induction period. Because of Rapamune's effectiveness and different safety profile, it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection.
To explore this further, the following study is designed to assess the use of SRL versus TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients.
Condition | Intervention | Phase |
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Pancreas Transplantation Kidney Transplantation |
Drug: Sirolimus Drug: Tacrolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 118 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2014 |
Arms | Assigned Interventions |
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2
In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation. In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time. |
Drug: Sirolimus
In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml. In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time. The initial dose will be 8 mg/day po. till a trough level is obtained and then titrated to maintain trough whole-blood concentrations between 5-15ng/ml. The dose of sirolimus will be administrated once a day. |
1
Patients receive Tacrolimus from day 0 to the end of the study (Arm Tacrolimus).
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Drug: Tacrolimus
Patients receive Tacrolimus from day 0 to the end of the study. The time of first administration will be within the first 48 hours post transplant. The dose of tacrolimus will be administrated twice a day. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml. Patients receive also rATG , mycophenolate mofetil and 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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diego CANTAROVICH, Doctor | diego.cantarovich@chu-nantes.fr |
France | |
CHU de Nantes | Recruiting |
Nantes, France | |
Contact: Diego CANTAROVICH, Doctor diego.cantarovich@chu-nantes.fr |
Principal Investigator: | Diego CANTAROVICH, Doctor | CHU Nantes |
Study ID Numbers: | BRD/04/2-D |
Study First Received: | June 5, 2008 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00693446 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Pancreas-kidney allograft tacrolimus sirolimus Pancreas-kidney allograft recipients |
Antilymphocyte Serum Sirolimus Clotrimazole Miconazole Tioconazole |
Mycophenolic Acid Mycophenolate mofetil Benzocaine Tacrolimus Pancrelipase |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents |