Renal TransplantPhase 3EVEROLDNCT01028092
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
A Phase 3 study testing Anti R-IL2 + Cyclosporine, Thymoglobulin + Everolimus and Anti R-IL2 + Cyclosporine then Everolimus in people with Renal Transplant, run by University Hospital, Brest at 18 sites in France.
Trial summary
This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Anti R-IL2 + Cyclosporine, Thymoglobulin + Everolimus and Anti R-IL2 + Cyclosporine then Everolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 18 sitesFrance
- Study dates
- Mar 2009to Jul 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has given written informed consent to participate in the study
- First or second single transplantation of a recipient (male or female) older than 60 years old
- Donor older than 60 years old
- PRA < 30%
Who cannot join
- Living donor
- Third transplantation
- PRA > 30%
- Other protocol-defined inclusion/exclusion criteria may apply.
- Recipient of multi-organ transplant
- Active major infections (HBV, HCV, HIV)
- Loss of a first graft for immunologic issues
- Anemia (<9g/l) or leucopenia (<2500/mm3)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU Amiens
Amiens
CHU Pellegrin - Bordeaux
Bordeaux
CHRU de BREST
Brest, 29609
CHU Cote de Nacre
Caen
CHU Clermont Ferrand
Clermont-Ferrand
CHU Dijon
Dijon
CHU Lille
Lille
CHU Limoges
Limoges
CHU Montpellier
Montpellier
CHU Nice
Nice
AP-HP Hopital Necker
Paris
CHU Poitiers
Poitiers
CHU Reims
Reims
CHU Rennes
Rennes
CHU Rouen
Rouen
Hopitaux Universitaires de Strasbourg
Strasbourg
CHU Rangueil - Toulouse
Toulouse
CHU Tours
Tours
About this study
This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).
- Conditions
- Renal Transplant
- Being tested
- Anti R-IL2 + Cyclosporine, Thymoglobulin + Everolimus, Anti R-IL2 + Cyclosporine then Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti R-IL2 + CyclosporineDrug
- anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
- Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
- cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2
- corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
Thymoglobulin + EverolimusDrug
- Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days
- Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0
- everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml
- corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
Anti R-IL2 + Cyclosporine then EverolimusDrug
- anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)
- Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0
- cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml
- corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids Receives: Drug: Anti R-IL2 + Cyclosporine |
| CNI-free | Experimental | Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids Receives: Drug: Thymoglobulin + Everolimus |
| Switch | Experimental | anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids Receives: Drug: Anti R-IL2 + Cyclosporine then Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculated renal function with MDRD equation
Measured: 12 months
Secondary outcomes (4)
Acute rejection rate
Measured: 12 months
Patient and graft survival rate
Measured: 12 months
Adverse events
Measured: 12 months
GFR calculated with Cockcroft Gault formula
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Roche Pharma AG, Genzyme, a Sanofi Company, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Yannick LE MEUR, MD/PhD, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028092
- Sponsor's protocol ID
- EVEROLD
- Other IDs
- RB 09.074
- Acronym
- EVEROLD
- Status last verified
- Jul 2014
- First submitted
- 8 Dec 2009
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation
- ClinicalTrials.gov ID
- NCT01028092
- Acronym / sponsor ID
- EVEROLD / EVEROLD
- Conditions
- Renal Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Novartis, Roche Pharma AG, Genzyme, a Sanofi Company, Ministry of Health, France
- Study start
- Mar 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Dec 2009 (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.
This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (>60 years old) recipients receiving graft from elderly donor(>60 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Anti R-IL2 + Cyclosporineanti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids |
| CNI-free | Experimental | Drug: Thymoglobulin + EverolimusThymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids |
| Switch | Experimental | Drug: Anti R-IL2 + Cyclosporine then Everolimusanti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who has given written informed consent to participate in the study
- First or second single transplantation of a recipient (male or female) older than 60 years old
- Donor older than 60 years old
- PRA < 30%
Key exclusion criteria (8 listed)
- Living donor
- Third transplantation
- PRA > 30%
- Other protocol-defined inclusion/exclusion criteria may apply.
- Recipient of multi-organ transplant
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 |
|---|---|---|
| Anti R-IL2 + Cyclosporine* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2 * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 | Drug | Control |
| Thymoglobulin + Everolimus* Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 | Drug | CNI-free |
| Anti R-IL2 + Cyclosporine then Everolimus* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0 * cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6 | Drug | Switch |
Primary outcome
calculated renal function with MDRD equation
Time frame: 12 months
4 secondary outcomes
Acute rejection rate
Time frame: 12 months
Patient and graft survival rate
Time frame: 12 months
Adverse events
Time frame: 12 months
GFR calculated with Cockcroft Gault formula
Time frame: 12 months
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 8 Jul 2014.
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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.
Yannick LE MEUR, MD/PhD principal investigator
CHU de Brest
18 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 Anti R-IL2 + Cyclosporine, Thymoglobulin + Everolimus and Anti R-IL2 + Cyclosporine then Everolimus in people with Renal Transplant, run by University Hospital, Brest at 18 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 4 inclusion and 8 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
calculated renal function with MDRD equation (time frame: 12 months). 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 8 Jul 2014.