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Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

NCT ID: NCT00461825

Last Updated: 2007-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Group C: CsAm

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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TOUCHARD Guy, MD,Professor

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital, POITIERS, 86021, FRANCE

Locations

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Caen university Hospital

Caen, , France

Site Status

Dupuytren University Hospital

Limoges, , France

Site Status

Poitiers University hospital

Poitiers, , France

Site Status

Reims University Hospital

Reims, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 10798748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9306349 (View on PubMed)

Other Identifiers

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Afssaps-980654

Identifier Type: -

Identifier Source: org_study_id