Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation - Full Text View

Sponsor:	Poitiers University Hospital
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00461825

Purpose

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
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:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Azathioprine sodium salt Cyclosporine Cyclosporin Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Azathioprine

U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:

to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
The incidence and the delay of occurrence of graft dysfunction episode defined as ³ 20 % increase in serum creatinine level (mean of three results obtained in the same laboratory) and requiring a graft biopsy.
Causes of graft dysfunction episodes diagnosed by graft biopsy.
The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)

Secondary Outcome Measures:

To compare the three treatment groups for the following parameters :
Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity
Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)
Adverse events
Patient and graft survival

Estimated Enrollment:	207
Study Start Date:	July 1998
Study Completion Date:	February 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:
- Primary cadaveric renal transplant with induction therapy, delayed Neoral, MMF and prednisone
- Steroid withdrawal >= 3 months before enrolment
- Bitherapy Neoral + CellCept
- Follow up time since transplantation : 11-24 months
- Recipient age >= 25 years
- Donor age <= 45 years
- Serum creatinine level <= 125 µmol/L and/or calculated creatinine clearance >= 50 ml/mn (CG formula)
- No or only one steroid-sensitive acute rejection episode during the first year post-transplantation
- PRA <= 25 %
- Written informed consent
Exclusion Criteria:
- Living donor transplantation
- Recipient receiving tacrolimus
- Azathioprine intolerance
- Thrombopenia < 100 000/mm³
- Neutropenia < 1500/mm³
- Hemoglobinemia <= 8g/dl
- On going infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461825

Locations

France
Caen university Hospital
Caen, France, 14033
Dupuytren University Hospital
Limoges, France, 87042
Poitiers University hospital
Poitiers, France, 86021
Reims University Hospital
Reims, France, 51092
Rouen University Hospital
Rouen, France, 76031

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator:

TOUCHARD Guy, MD,Professor

Poitiers University Hospital, POITIERS, 86021, FRANCE

More Information

Publications:

Hurault de Ligny B, Toupance O, Lavaud S, Bauwens M, Peyronnet P, Le Meur Y, Ryckelynck JP, Jolly D, Leroux-Robert C, Touchard G. Factors predicting the long-term success of maintenance cyclosporine monotherapy after kidney transplantation. Transplantation. 2000 Apr 15;69(7):1327-32.

Touchard G, Hauet T, Cogny Van Weydevelt F, Hurault de Ligny B, Peyronnet P, Lebranchu Y, Toupance O, N'Doye P, Busson M. Maintenance cyclosporin monotherapy after renal transplantation--clinical predictors of long-term outcome. Nephrol Dial Transplant. 1997 Sep;12(9):1956-60.

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

Keywords provided by Poitiers University Hospital:

Immunosuppression
Kidney transplantation
multicenter study

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Cyclosporine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Azathioprine
Antifungal Agents
Therapeutic Uses
Mycophenolate mofetil
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on March 18, 2010