Liver TransplantationPhase 2NCT01128335
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
A Phase 2 study of Liver Transplantation, run by Novartis Pharmaceuticals at 39 sites in 12 countries.
Trial summary
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 39 sitesin 12 countries
- Study dates
- Apr 2010to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of any race, 18 years or older
- Recipients of primary de novo orthotopic liver transplant from a deceased donor
- Recipients of a kidney with a cold ischemia time < 30 hours
- HCV-negative recipients
Who cannot join
- Prior organ/cellular transplant or multiple organ transplant
- MELD-score > 35
- HCC > Milan criteria
- Donor age < 12 years
- Cold ischemia > 15 hours
- Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
39 sites in 12 countries.
39 sites in 12 countries
United States8 sites
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Dallas, Texas, 75246
Novartis Investigative Site
Detroit, Michigan, 48202-2689
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Minneapolis, Minnesota, 55455
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
San Francisco, California, 94143
France6 sites
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Chambray-lès-Tours, 37044
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Paris, 75012
Novartis Investigative Site
Strasbourg, 67098
Novartis Investigative Site
Villejuif, 94805
Germany6 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Regensburg, 93053
Spain4 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Valencia, Valencia, 46026
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1118AAT
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
San Martín, Buenos Aires, C1107BEA
Italy3 sites
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Pisa, PI, 56124
Austria2 sites
Novartis Investigative Site
Innsbruck, A-6020
Novartis Investigative Site
Vienna, A-1090
Belgium2 sites
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Czechia2 sites
Novartis Investigative Site
Brno, 656 91
Novartis Investigative Site
Prague, Czech Republic, 140 21
About this study
Official title: A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
- Conditions
- Liver Transplantation
- Being tested
- MMF(1000mg bid) + tacrolimus + standard of care medications, sotrastaurin (200mg bid) + tacrolimus + standard of care medications, sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
- Keywords
- Liver transplantation, HCV-negative recipient, deceased donor, sotrastaurin, oran transplantation, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMF(1000mg bid) + tacrolimus + standard of care medicationsDrug
MMF(1000mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medicationsDrug
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medicationsDrug
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (300 mg bid) + tacrolimus + standard of care medicationsDrug
sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | MMF(1000mg bid) + tacrolimus + standard of care medications Receives: Drug: MMF(1000mg bid) + tacrolimus + standard of care medications |
| Arm 2 | Experimental | sotrastaurin (200mg bid) + tacrolimus + standard of care medications Receives: Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| Arm 3 | Experimental | sotrastaurin (200mg bid) + tacrolimus + standard of care medications Receives: Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| Arm 4 | Experimental | sotrastaurin (300 mg bid) + tacrolimus + standard of care medications Receives: Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Measured: Month 6
Secondary outcomes (4)
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).
Measured: Months 3, 6, 12, and 24
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Measured: Months 12, 24
Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant
Measured: Months 6, 12, 24
Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).
Measured: Months 3, 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
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 Liver 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128335
- Sponsor's protocol ID
- CAEB071B2201
- Other IDs
- 2007-001776-36
- Status last verified
- Nov 2016
- First submitted
- 20 May 2010
- Last updated
- 22 Dec 2020
- Results posted
- No
Publications
Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.
PubMed 25677074
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 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01128335
- Acronym / sponsor ID
- CAEB071B2201
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, HCV-negative recipient, deceased donor, sotrastaurin, oran transplantation, tacrolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 May 2010 (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 the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: MMF(1000mg bid) + tacrolimus + standard of care medicationsMMF(1000mg bid) + tacrolimus + standard of care medications |
| Arm 2 | Experimental | Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medicationssotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| Arm 3 | Experimental | Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medicationssotrastaurin (200mg bid) + tacrolimus + standard of care medications |
| Arm 4 | Experimental | Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medicationssotrastaurin (300 mg bid) + tacrolimus + standard of care medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients of any race, 18 years or older
- Recipients of primary de novo orthotopic liver transplant from a deceased donor
- Recipients of a kidney with a cold ischemia time < 30 hours
- HCV-negative recipients
Key exclusion criteria (7 listed)
- Prior organ/cellular transplant or multiple organ transplant
- MELD-score > 35
- HCC > Milan criteria
- Donor age < 12 years
- Cold ischemia > 15 hours
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 |
|---|---|---|
| MMF(1000mg bid) + tacrolimus + standard of care medicationsMMF(1000mg bid) + tacrolimus + standard of care medications | Drug | Arm 1 |
| sotrastaurin (200mg bid) + tacrolimus + standard of care medicationssotrastaurin (200mg bid) + tacrolimus + standard of care medications | Drug | Arm 2 |
| sotrastaurin (200mg bid) + tacrolimus + standard of care medicationssotrastaurin (200mg bid) + tacrolimus + standard of care medications | Drug | Arm 3 |
| sotrastaurin (300 mg bid) + tacrolimus + standard of care medicationssotrastaurin (300 mg bid) + tacrolimus + standard of care medications | Drug | Arm 4 |
Primary outcome
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Time frame: Month 6
4 secondary outcomes
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).
Time frame: Months 3, 6, 12, and 24
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
Time frame: Months 12, 24
Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant
Time frame: Months 6, 12, 24
Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).
Time frame: Months 3, 6, 12, 24
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.
- Results publication: PubMed 25677074Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.
- Results for CAEB071B2201 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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
Novartis Pharmceuticals study director
Novartis Pharmaceuticals
39 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Liver Transplantation, run by Novartis Pharmaceuticals at 39 sites in 12 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 4 inclusion and 7 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 39 sites in United States, France, Germany, Spain, Argentina and 7 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?
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms. (time frame: Month 6). 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 NCT01128335, 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.