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Sponsored by: |
Poitiers University Hospital |
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Information provided by: | Poitiers University Hospital |
ClinicalTrials.gov Identifier: | NCT00461825 |
We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332).
These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: Cyclosporin A: C0: 75–125ng/ml-dose adapted in the 3 groups Drug: Group A: CsA + Azathioprine(1 to 2 mg/kg/day) Drug: Group B: CsA + CellCept(500 mg x 2/day) Drug: Group C: CsAm |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation |
Estimated Enrollment: | 207 |
Study Start Date: | July 1998 |
Study Completion Date: | February 2007 |
Between july 1998 and january 2004 selected patients were randomly assigned equally within each centre to receive CsAm or bitherapy with equally CsA + MMF or CsA + AZA.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
France | |
Caen university Hospital | |
Caen, France, 14033 | |
Dupuytren University Hospital | |
Limoges, France, 87042 | |
Rouen University Hospital | |
Rouen, France, 76031 | |
Reims University Hospital | |
Reims, France, 51092 | |
Poitiers University hospital | |
Poitiers, France, 86021 |
Principal Investigator: | TOUCHARD Guy, MD,Professor | Poitiers University Hospital, POITIERS, 86021, FRANCE |
Study ID Numbers: | Afssaps-980654 |
Study First Received: | March 30, 2007 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00461825 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Immunosuppression Kidney transplantation multicenter study |
Antimetabolites Anti-Infective Agents Azathioprine Cyclosporine Immunologic Factors |
Antifungal Agents Mycophenolate mofetil Antirheumatic Agents Immunosuppressive Agents Cyclosporins |
Antimetabolites Anti-Infective Agents Cyclosporine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Azathioprine Antifungal Agents Therapeutic Uses Mycophenolate mofetil Antirheumatic Agents Dermatologic Agents |