Kidney TransplantationPhase 1/2NCT00403416
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
A Phase 1/2 study testing AEB071 and Mycophenolic Acid in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 28 sites in 8 countries.
Trial summary
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter. 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 and Mycophenolic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 28 sitesin 8 countries
- Study dates
- Oct 2006to May 2008
- Phase
- Phase 1/2
- 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 of any race 18 years or older
- Adult recipients of a kidney transplant from a deceased or from a living donor
- Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.
Who cannot join
- Need for medication prohibited by the protocol
- Patients or donors infected with hepatitis B or C, or with HIV.
- Patients with a history of cancer
- Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Germany6 sites
Universitaetsklinik Charite
Berlin, 10117
Klinikum der Humboldt Universitat Charite
Berlin, 13353
Staedt. Krankenhaus Koeln-Merheim
Cologne, 51109
Universitaetsklinikum Essen
Essen, 45122
Medizinische Hochschule Hannover
Hanover, 30625
Univ. - Klinikum Heidelberg
Heidelberg, 69120
France4 sites
Hopital Kremlin Bicetre
Le Kremlin-Bicêtre, 94270
Hopital Hotel Dieu
Nantes, 44035
Hopital Necker
Paris, 75015
CHU de Rangueil
Toulouse, 31403
Spain4 sites
Ciutat Santitaria I Univessitaria de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital 12 de Octubre
Madrid, 28041
Complejo Hospitalario Carlos Haya
Málaga, 28041
Hospital Doctor Peset
Valencia, 46017
United Kingdom4 sites
University Hospital of Wales
Cardiff, CF14 4XW
Western Infirmary
Glasgow, G11 6NT
Saint George's University of London
London
Manchester Royal Infirmary
Manchester
United States3 sites
University Hospitals of Cleveland
Cleveland, Ohio, 44106-5048
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-7375
University of California, San Francisco
San Francisco, California, 94143-0780
Italy3 sites
Az. Osp. Di Bologna Polici. S. Orsola - Malpighi
Bologna, 40138
Azienda Opedaliera Careggi - Universita degli Studi
Florence, 50134
Azienda Ospedaliera di Padova - Universita degli Studi
Padova, 35128
Switzerland3 sites
Universitatsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
Universitätsspital Zürich
Zurich, 8091
About this study
Official title: 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
- Conditions
- Kidney Transplantation
- Being tested
- AEB071, Mycophenolic Acid
- Keywords
- AEB071, Tacrolimus, Mycophenolic acid, Basiliximab, Rejection, Kidney function, Immunosuppression
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
Mycophenolic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolic Acid / tacrolimus | Active comparator | Not described Receives: Drug: Mycophenolic Acid |
| AEB071 / tacrolimus arm 1 | Experimental | Not described Receives: Drug: AEB071 |
| AEB071 / tacrolimus arm 2 | Experimental | Not described Receives: Drug: AEB071 |
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
Measured: at 6 months
Secondary outcomes (5)
Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
Measured: at 6 months
Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up
Measured: at 3 and 12 months
Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
Measured: at Month 3, 6 and 12
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms
Measured: from Month 3 to Month 6
Safety and tolerability
Measured: at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2008
- Study completionMay 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 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
- NCT00403416
- Sponsor's protocol ID
- CAEB071A2203
- Status last verified
- May 2017
- First submitted
- 22 Nov 2006
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00403416
- Acronym / sponsor ID
- CAEB071A2203
- Conditions
- Kidney Transplantation
- Keywords
- AEB071, Tacrolimus, Mycophenolic acid, Basiliximab, Rejection, Kidney function, Immunosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 23 Nov 2006 (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 evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mycophenolic Acid / tacrolimus | Active comparator | Drug: Mycophenolic Acid |
| AEB071 / tacrolimus arm 1 | Experimental | Drug: AEB071 |
| AEB071 / tacrolimus arm 2 | Experimental | Drug: AEB071 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients of any race 18 years or older
- Adult recipients of a kidney transplant from a deceased or from a living donor
- Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.
Key exclusion criteria (5 listed)
- Need for medication prohibited by the protocol
- Patients or donors infected with hepatitis B or C, or with HIV.
- Patients with a history of cancer
- Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.
- 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 |
|---|---|---|
| AEB071 | Drug | AEB071 / tacrolimus arm 1, AEB071 / tacrolimus arm 2 |
| Mycophenolic Acid | Drug | Mycophenolic Acid / tacrolimus |
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
Time frame: at 6 months
5 secondary outcomes
Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
Time frame: at 6 months
Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up
Time frame: at 3 and 12 months
Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
Time frame: at Month 3, 6 and 12
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms
Time frame: from Month 3 to Month 6
Safety and tolerability
Time frame: at 3, 6 and 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 17 Dec 2020.
- Results for CAEB071A2203 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AEB071 and Mycophenolic Acid in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 28 sites in 8 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 3 inclusion and 5 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 17 Dec 2020. 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 Germany, France, Spain, United Kingdom, United States and 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (time frame: at 6 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 17 Dec 2020.