Renal TransplantationPhase 4NCT00200551
A Study of Mycophenolate Mofetil and Cyclosporin, Without Concomitant Corticosteroids, After a First Renal Transplant
A Phase 4 study testing Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids. and Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids. in people with Renal Transplantation, run by Nantes University Hospital at 5 sites in France.
Trial summary
The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids. and Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2001to Apr 2010
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes
- Man or woman aged between 18 and 65 years
- Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study
- Donor aged between 18 and 65 years
- Patient who has been given full information about the study and who has given his written informed consent to take part in it.
Who cannot join
- Women who are pregnant or breast-feeding
- Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes)
- Patient with a history of allergy to rabbit proteins
- Cold ischaemia time of more than 36 hours
- Patient allergic to macrolide antibiotics, to tacrolimus or to MMF
- Patient on immunosuppressant treatment before transplantation
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- Patient suffering from a malignant neoplasm or with a history of malignant neoplasia, with the exception of treated baso- or spinocellular cancers
- Patient waiting for another transplant in addition to the kidney
- Patient who has already received an organ or tissue graft
- Leukocyte count <2000/mm3 and/or platelet count <50 000/mm3
- Patient suffering from focal glomerulonephritis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Besançon Universitary Hospital
France, Besançon, 25030
Montpellier Universitary Hospital
Montpellier, 34059
Nantes University Hospital
Nantes, 44093
Nice Universitary Hospital
Nice, 06202
Strasbourg Universitary Hospital
Strasbourg, 67091
About this study
Official title: A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant
The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.
- Conditions
- Renal Transplantation
- Being tested
- Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids., Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids.Drug
Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the number of acute rejection episodes during the first year after transplantation in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids.
Secondary outcomes (8)
Clinical tolerance of the treatment with antilymphocyte
Any complication related to the corticosteroid treatment
Graft survival at 1, 2, 3, 4 and 5 years
Patient survival at 1, 2, 3, 4 and 5 years
Incidence of infectious and tumoral complications at 1, 2, 3, 4 and 5 years
Incidence of cardiovascular complications at 1, 2, 3, 4 and 5 years
Incidence of metabolic and lipid disorders at 1, 2, 3, 4 and 5 years
Bone osteodensitometry and folic acid levels before transplantation and at 2 weeks, 3 and 6 month after transplantation; then yearly up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2001
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Diego CANTAROVICH, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200551
- Sponsor's protocol ID
- BRD/00/06-G
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2005
- Last updated
- 14 Sep 2026
- Results posted
- No
Publications
Cantarovich D, Rostaing L, Kamar N, Saint-Hillier Y, Ducloux D, Mourad G, Garrigue V, Wolf P, Ellero B, Cassuto E, Albano L, Soulillou JP; FRANCIA Study Trial Investigators Group. Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction. Transpl Int. 2010 Mar 1;23(3):313-24. doi: 10.1111/j.1432-2277.2009.00971.x. Epub 2009 Oct 19.
PubMed 19843296
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant
- ClinicalTrials.gov ID
- NCT00200551
- Acronym / sponsor ID
- BRD/00/06-G
- Conditions
- Renal Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who is a candidate for a first cadaver renal transplantation and included on the national list of the Etablissement Français des Greffes
- Man or woman aged between 18 and 65 years
- Women of reproductive age must agree to use a reliable contraceptive method throughout the first year of the study
- Donor aged between 18 and 65 years
- Patient who has been given full information about the study and who has given his written informed consent to take part in it.
Key exclusion criteria (11 listed)
- Women who are pregnant or breast-feeding
- Patient with an immunological risk considered high and defined as a percentage of anti-HLA antibodies of ³20% (previous or recent determination of T lymphocytes)
- Patient with a history of allergy to rabbit proteins
- Cold ischaemia time of more than 36 hours
- Patient allergic to macrolide antibiotics, to tacrolimus or to MMF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids. | Drug | – |
| Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids. | Drug | – |
Primary outcome
To evaluate the number of acute rejection episodes during the first year after transplantation in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids.
8 secondary outcomes
Clinical tolerance of the treatment with antilymphocyte
Any complication related to the corticosteroid treatment
Graft survival at 1, 2, 3, 4 and 5 years
Patient survival at 1, 2, 3, 4 and 5 years
Incidence of infectious and tumoral complications at 1, 2, 3, 4 and 5 years
Incidence of cardiovascular complications at 1, 2, 3, 4 and 5 years
Incidence of metabolic and lipid disorders at 1, 2, 3, 4 and 5 years
Bone osteodensitometry and folic acid levels before transplantation and at 2 weeks, 3 and 6 month after transplantation; then yearly up to 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 19843296Cantarovich D, Rostaing L, Kamar N, Saint-Hillier Y, Ducloux D, Mourad G, Garrigue V, Wolf P, Ellero B, Cassuto E, Albano L, Soulillou JP; FRANCIA Study Trial Investigators Group. Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction. Transpl Int. 2010 Mar 1;23(3):313-24. doi: 10.1111/j.1432-2277.2009.00971.x. Epub 2009 Oct 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego CANTAROVICH, MD principal investigator
Nantes UH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporin, mycophenolate mofetil, antilymphocyte serum and corticoids. and Cyclosporin, mycophenolate mofetil, antilymphocyte serum without corticoids. in people with Renal Transplantation, run by Nantes 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 5 inclusion and 11 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 14 Sep 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 evaluate the number of acute rejection episodes during the first year after transplantation in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids.. 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 NCT00200551, which also lists 1 linked publication.
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 14 Sep 2026.