Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

Kidney Transplantation Clinical Trial

Official title:

Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461825
• Other study ID #: Afssaps-980654
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2007
• Last updated: April 17, 2007
• Start date: July 1998
• Est. completion date: February 2007

Study information

• Verified date: April 2007
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Cyclosporin A: C0: 75–125ng/ml-dose adapted in the 3 groups

• Group A: CsA + Azathioprine(1 to 2 mg/kg/day)

• Group B: CsA + CellCept(500 mg x 2/day)

• Group C: CsAm

Locations

Country	Name	City	State
France	Caen university Hospital	Caen
France	Dupuytren University Hospital	Limoges
France	Poitiers University hospital	Poitiers
France	Reims University Hospital	Reims
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
Primary	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.
Primary	Causes of graft dysfunction episodes diagnosed by graft biopsy.
Primary	The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)
Secondary	To compare the three treatment groups for the following parameters :
Secondary	Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity
Secondary	Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)
Secondary	Adverse events
Secondary	Patient and graft survival