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NCT Number: NCT00461825

Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

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.

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Key information

Conditions

Kidney Transplantation

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caen university Hospital, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Drug

Primary outcomes

  1. to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :

  2. 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.

  3. Causes of graft dysfunction episodes diagnosed by graft biopsy.

  4. The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)

Secondary outcomes

  1. To compare the three treatment groups for the following parameters :

  2. Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity

  3. Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)

  4. Adverse events

  5. Patient and graft survival

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
2007
First posted
Apr 18, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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