Kidney TransplantationPhase 2AEB071NCT00504543
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients
A Phase 2 study testing AEB071, Certican and Neoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 26 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 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- AEB071, Certican and Neoral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 26 sitesin 17 countries
- Study dates
- Jul 2007to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 years or older
- Recipients of first kidney transplant from a deceased or living not related donor
Who cannot join
- Need for medication prohibited in the study
- Patients with heart disease (own or family history)
- Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
- Patients with high immunological risks
- Patients with a history of cancer
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
26 sites in 17 countries.
26 sites in 17 countries
Argentina2 sites
Argentina
Buenos Aires, 1107
Novartis Investigative Site
Buenos Aires, 1425
Colombia2 sites
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Cali
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Heidelberg, 69120
Slovakia2 sites
Novartis Investigative Site
Banská Bystrica, 97517
Novartis Investigative Site
Košice, 04066
About this study
Official title: A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, 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
- AEB071, Certican, Neoral
- Keywords
- Kidney transplant, AEB071
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
oral, twice daily
CerticanDrug
twice daily
NeoralDrug
twice daily
| Study group | Role | What they receive |
|---|---|---|
| Neoral | Active comparator | Not described Receives: Drug: Neoral |
| AEB071 high dose with Cetican reduced dose | Active comparator | Not described Receives: Drug: AEB071; Drug: Certican |
| AEB071 low dose with Cetican standard dose | Active comparator | Not described Receives: Drug: AEB071; Drug: Certican |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.
Measured: 12 months
Secondary outcomes (1)
Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK
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 posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2011
- Study completionApr 2011
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 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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504543
- Sponsor's protocol ID
- CAEB071A2206
- Acronym
- AEB071
- Status last verified
- Nov 2016
- First submitted
- 19 Jul 2007
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.
PubMed 23659755
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, 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
- NCT00504543
- Acronym / sponsor ID
- AEB071 / CAEB071A2206
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplant, AEB071
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jul 2007 (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 |
|---|---|---|
| Neoral | Active comparator | Drug: Neoral |
| AEB071 high dose with Cetican reduced dose | Active comparator | Drug: AEB071, Drug: Certican |
| AEB071 low dose with Cetican standard dose | Active comparator | Drug: AEB071, Drug: Certican |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients 18 years or older
- Recipients of first kidney transplant from a deceased or living not related donor
Key exclusion criteria (6 listed)
- Need for medication prohibited in the study
- Patients with heart disease (own or family history)
- Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
- Patients with high immunological risks
- Patients with a history of cancer
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 |
|---|---|---|
| AEB071oral, twice daily | Drug | AEB071 high dose with Cetican reduced dose, AEB071 low dose with Cetican standard dose |
| Certicantwice daily | Drug | AEB071 high dose with Cetican reduced dose, AEB071 low dose with Cetican standard dose |
| Neoraltwice daily | Drug | Neoral |
Primary outcome
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.
Time frame: 12 months
1 secondary outcome
Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK
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 18 Nov 2016.
- Results publication: PubMed 23659755Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.
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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 study director
Novartis
26 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 AEB071, Certican and Neoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 26 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 2 inclusion and 6 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Argentina, Australia, Austria, Colombia, France 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?
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation. (time frame: 12 months). 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 NCT00504543, 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 18 Nov 2016.