NCT00461825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

March 30, 2007

Last Update Submit

April 17, 2007

Conditions

Kidney Transplantation

Keywords

ImmunosuppressionKidney transplantationmulticenter study

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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

Interventions

Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groupsDRUG
Group A: CsA + Azathioprine(1 to 2 mg/kg/day)DRUG
Group B: CsA + CellCept(500 mg x 2/day)DRUG
Group C: CsAmDRUG

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Caen university Hospital

Caen, 14033, France

Location

Dupuytren University Hospital

Limoges, 87042, France

Location

Poitiers University hospital

Poitiers, 86021, France

Location

Reims University Hospital

Reims, 51092, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Related 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. doi: 10.1097/00007890-200004150-00019.

    PMID: 10798748BACKGROUND

  • 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. doi: 10.1093/ndt/12.9.1956.

    PMID: 9306349BACKGROUND

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • TOUCHARD Guy, MD,Professor

    Poitiers University Hospital, POITIERS, 86021, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 18, 2007

Study Start

July 1, 1998

Study Completion

February 1, 2007

Last Updated

April 18, 2007

Record last verified: 2007-04

Locations

FR(5)