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Kidney TransplantationPhase 3NCT00461825

Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation

A Phase 3 study testing Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups, Group A: CsA + Azathioprine(1 to 2 mg/kg/day) and Group B: CsA + CellCept(500 mg x 2/day) in people with Kidney Transplantation, run by Poitiers University Hospital at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups, Group A: CsA + Azathioprine(1 to 2 mg/kg/day) and Group B: CsA + CellCept(500 mg x 2/day)
How many people
207 participants
Where
5 sitesFrance
Study dates
Jul 1998to Feb 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Caen university Hospital

    Caen, 14033

  • Dupuytren University Hospital

    Limoges, 87042

  • Poitiers University hospital

    Poitiers, 86021

  • Reims University Hospital

    Reims, 51092

  • Rouen University Hospital

    Rouen, 76031

Other trials in France

About this study

Official title: Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept 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.

Read the 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.

Being tested
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
Keywords
Immunosuppression, Kidney transplantation, multicenter study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (5)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2007 (estimated)
  2. Study startJul 1998
  3. Study completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
207 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461825
Sponsor's protocol ID
Afssaps-980654
Status last verified
Apr 2007
First submitted
30 Mar 2007
Last updated
18 Apr 2007
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10798748

  • 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.

    PubMed 9306349

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclosporin A: C0: 75-125ng/ml-dose adapted in the 3 groups, Group A: CsA + Azathioprine(1 to 2 mg/kg/day) and Group B: CsA + CellCept(500 mg x 2/day) in people with Kidney Transplantation, run by Poitiers University Hospital at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00461825, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.

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