Kidney TransplantationPhase 2NCT00555789
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
A Phase 2 study testing AEB071 and mycophenolic plus tacrolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 27 sites in 8 countries.
Trial summary
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus 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 and mycophenolic plus tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 27 sitesin 8 countries
- Study dates
- Oct 2007to Mar 2008
- 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
- Participation in core study CAEB071A2203
- The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
- Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
Who cannot join
- Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
Germany6 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cologne
Novartis Investigative Site
Essen, 45122
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
France4 sites
Novartis Investigative Site
Le Kremlin-Bicêtre, 94270
Novartis Investigative Site
Nantes, 44035
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Toulouse, 31403
Spain4 sites
Novartis Investigative Site
Llobregat, 08907
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Málaga, 28041
Novartis Investigative Site
Valencia, 46017
United Kingdom4 sites
Novartis Investigative Site
Cardiff, CF14 4XW
Novartis Investigative Site
Glasgow, G11 6NT
Novartis Investigative Site
London
Novartis Investigative Site
Manchester
Italy3 sites
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Florence, 50134
Novartis Investigative Site
Padova, 35128
Switzerland3 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Zurich, 8091
United States2 sites
Novartis Investigative Site
Madison, Wisconsin, 53706
Novartis Investigative Site
San Francisco, California, 94143-0780
About this study
Official title: A 24 Month Extension to a 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 provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- AEB071, mycophenolic plus tacrolimus
- Keywords
- kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic acid, 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
Also called mycophenolic plus tacrolimus
200mg oral b.i.d.
mycophenolic plus tacrolimusDrug
720mg b.i.d. 2yrs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | mycophenolic and tacrolimus Receives: Drug: mycophenolic plus tacrolimus |
| 2 | Experimental | mycophenolic and tacrolimus Receives: Drug: AEB071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months.
Measured: three Yrs
Secondary outcomes (1)
Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms.
Measured: Three yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMar 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 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
- NCT00555789
- Sponsor's protocol ID
- AEB071A2203E1
- Status last verified
- Jul 2012
- First submitted
- 8 Nov 2007
- 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
- A 24 Month Extension to a 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
- NCT00555789
- Acronym / sponsor ID
- AEB071A2203E1
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, rejection, AEB071, tacrolimus, mycophenolic acid, immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Nov 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 provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mycophenolic plus tacrolimusmycophenolic and tacrolimus |
| 2 | Experimental | Drug: AEB071mycophenolic and tacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in core study CAEB071A2203
- The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
- Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
Key exclusion criteria (1 listed)
- Pregnancy. 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 |
|---|---|---|
| AEB071Also: mycophenolic plus tacrolimus200mg oral b.i.d. | Drug | 2 |
| mycophenolic plus tacrolimus720mg b.i.d. 2yrs | Drug | 1 |
Primary outcome
Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months.
Time frame: three Yrs
1 secondary outcome
Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms.
Time frame: Three yrs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CAEB071A2203E1 on 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 study director
Novartis
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEB071 and mycophenolic plus tacrolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 27 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 1 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: stopped early, 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 27 sites in Germany, France, Spain, United Kingdom, Italy 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 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 was stopped early. Results are not available in the source record.
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?
Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months. (time frame: three Yrs). 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.