Kidney TransplantationPhase 1/2NCT00492869
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
A Phase 1/2 study testing AEB071 in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 41 sites in 7 countries.
Trial summary
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation. 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
- How many people
- 124 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Jan 2007to 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 kidney transplant from a deceased or living donor
- Recipients of a functioning kidney within 24 hours post transplant
Who cannot join
- Need for medication prohibited by the protocol
- Patients or donors infected with Hepatitis B,C or HIV
- Patients with a history of cancer within last 5 years
- Patients with history of significant cardiac disorder
- Patients of high-risk immunological status
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States23 sites
University of Michigan Health System
Ann Arbor, Michigan
U of Maryland Medical Center
Baltimore, Maryland
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
University of Cincinnati, Dept of Internal Medicine
Cincinnati, Ohio
Baylor U Medical Center
Dallas, Texas
University of Colorado Health Science Center
Denver, Colorado, 80262
Henry Ford Hospital Transplant Institute
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555 - 0561
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
USC Medical Center
Los Angeles, California, 90033
U of Wisconsin Hospital Clinics
Madison, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin
Mount Sinai Medical Center
New York, New York, 10029
Comprehensive Transplant Clinic
New York, New York
University of Pennsylvania Health System-Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah
University of California San Diego
San Diego, California, 92103-8401
California Pacific Medical Center
San Francisco, California, 94115
UCSF
San Francisco, California, 94143
Lifelink, Inc.
Tampa, Florida
University of Toledo Health Science Campus
Toledo, Ohio
Germany6 sites
Klinikum der Humboldt Universitat Charite
Berlin
Universitaetsklinik Charité
Berlin
Staedt. Kliniken Koeln-Merheim
Cologne
Medizinische Hochschule Hannover
Hanover
Univ.-Klinikum Heidelberg
Heidelberg
Klinikum der Universitaet Regensburg
Regensburg
Canada3 sites
Queen Elizabeth II
Halifax
Saint Joseph's Hospital
Hamilton, Ontario
Hopital Maisonneuve-Rosemont
Montreal Quebec
United Kingdom3 sites
Addenbrookes Hospital
Cambridge
Leicester General Hospital
Leicester
Churchill Hospital
Oxford
Sweden2 sites
Enheten f Transpl och Leverkir, SU/Sahlgrenska
Gothenburg
Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
Uppsala
About this study
Official title: A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- AEB071
- Keywords
- kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic, basiliximab, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms
Secondary outcomes (1)
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 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
- NCT00492869
- Sponsor's protocol ID
- CAEB071A2207
- Status last verified
- Sep 2016
- First submitted
- 26 Jun 2007
- Last updated
- 22 Dec 2020
- Results posted
- No
Publications
Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.
PubMed 21564523
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00492869
- Acronym / sponsor ID
- CAEB071A2207
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic, basiliximab, immunosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- First posted
- 27 Jun 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.
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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 kidney transplant from a deceased or living donor
- Recipients of a functioning kidney within 24 hours post transplant
Key exclusion criteria (6 listed)
- Need for medication prohibited by the protocol
- Patients or donors infected with Hepatitis B,C or HIV
- Patients with a history of cancer within last 5 years
- Patients with history of significant cardiac disorder
- Patients of high-risk immunological status
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 | – |
Primary outcome
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms
1 secondary outcome
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
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 22 Dec 2020.
- Derived from this study: PubMed 21564523Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.
- Results for CAEB071A2207 from the Novartis Clinical Trials websiteLink provided by the sponsor.
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AEB071 in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 41 sites in 7 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 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 22 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 41 sites in United States, Germany, Canada, United Kingdom, Belgium and 2 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?
Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms. 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 NCT00492869, 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 22 Dec 2020.