Kidney TransplantationPhase 2NCT00820911
Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients
A Phase 2 study testing cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus and AEB071 200 mg b.i.d. / everolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 28 sites in 17 countries.
Trial summary
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus and AEB071 200 mg b.i.d. / everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 28 sitesin 17 countries
- Study dates
- Sep 2008to Jul 2012
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been maintained on study drug for 12 months in the core study
Who cannot join
- Not applicable
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
28 sites in 17 countries.
28 sites in 17 countries
Australia3 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Woodville, South Australia, 5011
France3 sites
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Nantes, 44035
Novartis Investigative Site
Toulouse, 31054
Argentina2 sites
Novartis Investigative Site
Córdoba, Córdoba Province, X5022CPU
Novartis Investigative Site
San Martín, Buenos Aires, C1107BEA
Brazil2 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Colombia2 sites
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Cali
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Heidelberg, 69120
Italy2 sites
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20162
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, Slovakia, 975 17
Novartis Investigative Site
Košice, Slovak Republic, 041 90
Spain2 sites
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, Madrid, 28034
About this study
Official title: An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
- Conditions
- Kidney Transplantation
- Being tested
- cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus, AEB071 200 mg b.i.d. / everolimus
- Keywords
- Kidney transplant, AEB071
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine (reduced exposure) / everolimusDrug
twice daily
AEB071 300 mg b.i.d. / everolimusDrug
twice daily
AEB071 200 mg b.i.d. / everolimusDrug
twice daily
| Study group | Role | What they receive |
|---|---|---|
| cyclosporine (reduced exposure) / everolimus | Active comparator | Not described Receives: Drug: cyclosporine (reduced exposure) / everolimus |
| AEB071 300 mg b.i.d. / everolimus | Experimental | Not described Receives: Drug: AEB071 300 mg b.i.d. / everolimus |
| AEB071 200 mg b.i.d. / everolimus | Experimental | Not described Receives: Drug: AEB071 200 mg b.i.d. / everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
Measured: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Secondary outcomes (1)
efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
Measured: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820911
- Sponsor's protocol ID
- CAEB071A2206E1
- Other IDs
- 2008-000531-18, 2008
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2009
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00820911
- Acronym / sponsor ID
- CAEB071A2206E1
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplant, AEB071
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jan 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 will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cyclosporine (reduced exposure) / everolimus | Active comparator | Drug: cyclosporine (reduced exposure) / everolimus |
| AEB071 300 mg b.i.d. / everolimus | Experimental | Drug: AEB071 300 mg b.i.d. / everolimus |
| AEB071 200 mg b.i.d. / everolimus | Experimental | Drug: AEB071 200 mg b.i.d. / everolimus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient has been maintained on study drug for 12 months in the core study
Key exclusion criteria (2 listed)
- Not applicable
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| cyclosporine (reduced exposure) / everolimustwice daily | Drug | cyclosporine (reduced exposure) / everolimus |
| AEB071 300 mg b.i.d. / everolimustwice daily | Drug | AEB071 300 mg b.i.d. / everolimus |
| AEB071 200 mg b.i.d. / everolimustwice daily | Drug | AEB071 200 mg b.i.d. / everolimus |
Primary outcome
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
1 secondary outcome
efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
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 24 Feb 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
28 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus and AEB071 200 mg b.i.d. / everolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 28 sites in 17 countries.
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 1 inclusion and 2 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Australia, France, Argentina, Brazil, Colombia and 12 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula (time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation). 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 24 Feb 2017.