Kidney FailurePhase 3CIMENCT01595984
Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)
A Phase 3 study testing cyclosporin + mycophenolate mofetil and everolimus + mycophenolate mofetil in people with Kidney Failure, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant. Renal function will be accurately evaluated by measuring the clearance of iohexol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- cyclosporin + mycophenolate mofetil and everolimus + mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesFrance
- Study dates
- 3 May 2012to 5 Mar 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females aged between 18 and 70.
- Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
- Patient with a maximum PRA <20%.
- Patient wishing and being able to participate fully to the study, and having given a written consent.
- Patient covered by a social insurance or beneficiary of such a regime.
- Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.
Who cannot join
- Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
- Patient with a maximum PRA> 20% twice.
- Cold ischemic time > 36 hours.
- Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
- Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
- Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
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- Patient with severe systemic infections requiring continued therapy.
- Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
- Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
- Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.
- Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
- Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
- Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
- Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
- Patient under guardianship, or any patient protected by law.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nephrology department, Hospital University of Amiens
Amiens, 80000
Nephrology Department, University Hospital of Montpellier
Montpellier, 34285
About this study
Official title: Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.
Renal function will be accurately evaluated by measuring the clearance of iohexol.
The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.
- Conditions
- Kidney Failure
- Being tested
- cyclosporin + mycophenolate mofetil, everolimus + mycophenolate mofetil
- Keywords
- kidney, transplantation, graft, creatinin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporin + mycophenolate mofetilDrug
antirejection drug, renal transplantation
everolimus + mycophenolate mofetilDrug
antirejection drug, renal transplantation
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporin + Mycophenolate mofetil | Active comparator | Not described Receives: Drug: cyclosporin + mycophenolate mofetil |
| Everolimus + mycophenolate mofetil | Experimental | Not described Receives: Drug: everolimus + mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of glomerular filtration rate measured by clearance of iohexol
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study start3 May 2012
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595984
- Sponsor's protocol ID
- PI10-PR-CHOUKROUN
- Other IDs
- 2011-001385-18
- Acronym
- CIME
- Status last verified
- Jun 2026
- First submitted
- 9 May 2012
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant
- ClinicalTrials.gov ID
- NCT01595984
- Acronym / sponsor ID
- CIME / PI10-PR-CHOUKROUN
- Conditions
- Kidney Failure
- Keywords
- kidney, transplantation, graft, creatinin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 3 May 2012 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 10 May 2012 (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 main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.
Renal function will be accurately evaluated by measuring the clearance of iohexol.
The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporin + Mycophenolate mofetil | Active comparator | Drug: cyclosporin + mycophenolate mofetil |
| Everolimus + mycophenolate mofetil | Experimental | Drug: everolimus + mycophenolate mofetil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females aged between 18 and 70.
- Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
- Patient with a maximum PRA <20%.
- Patient wishing and being able to participate fully to the study, and having given a written consent.
- Patient covered by a social insurance or beneficiary of such a regime.
Key exclusion criteria (15 listed)
- Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
- Patient with a maximum PRA> 20% twice.
- Cold ischemic time > 36 hours.
- Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
- Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
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 mofetilantirejection drug, renal transplantation | Drug | Cyclosporin + Mycophenolate mofetil |
| everolimus + mycophenolate mofetilantirejection drug, renal transplantation | Drug | Everolimus + mycophenolate mofetil |
Primary outcome
Evolution of glomerular filtration rate measured by clearance of iohexol
Time frame: one year
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 12 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclosporin + mycophenolate mofetil and everolimus + mycophenolate mofetil in people with Kidney Failure, run by Centre Hospitalier Universitaire, Amiens at 2 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 6 inclusion and 15 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Evolution of glomerular filtration rate measured by clearance of iohexol (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.