Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

Phase 3

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00461825
• Lead Sponsor: Poitiers University Hospital

Brief 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.

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.

Study Timeline

• Study Start: 1998-07
• Study Completion: 2007-02
• Study First Submitted: 2007-03-30
• Status Verified: 2007-04
• Study First Submitted QC: 2007-04-17
• Last Update Submitted: 2007-04-17
• Study First Posted: 2007-04-18
• Last Update Posted: 2007-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

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Exclusion Criteria

• Living donor transplantation
  • Recipient receiving tacrolimus
  • Azathioprine intolerance
  • Thrombopenia < 100 000/mm³
  • Neutropenia < 1500/mm³
  • Hemoglobinemia <= 8g/dl
  • On going infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Reims University Hospital; 🇫🇷 Reims, France

Dupuytren University Hospital; 🇫🇷 Limoges, France

Rouen University Hospital; 🇫🇷 Rouen, France

Poitiers University hospital; 🇫🇷 Poitiers, France

Caen university Hospital; 🇫🇷 Caen, France