Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
2 other identifiers
interventional
298
15 countries
44
Brief 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 renal transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 22, 2020
November 1, 2016
2.7 years
February 2, 2010
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).
Month 6
Secondary Outcomes (4)
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)
Months 6, 12, 24, and 36
Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).
Months 12, 24, and 36
Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).
Months 6, 12, 24, and 36
Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).
Months 6, 12, 24, and 36
Study Arms (4)
Arm 1
EXPERIMENTALsotrastaurin (100mg bid) + tacrolimus + standard of care medications
Arm 2
EXPERIMENTALsotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 3
EXPERIMENTALsotrastaurin (300mg bid) + tacrolimus + standard of care medications
Arm 4
ACTIVE COMPARATORmycophenolic acid (720mg bid) + tacrolimus + standard of care medications
Interventions
sotrastaurin (100mg bid) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
sotrastaurin (300mg bid) + tacrolimus + standard of care medications
mycophenolic acid (720mg bid) + tacrolimus + standard of care medications
Eligibility Criteria
You may qualify if:
- Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
- Recipients of a kidney with a cold ischemia time \< 30 hours.
- Recipients of a kidney from a donor 10 - 65 years old.
You may not qualify if:
- Multi-organ transplant recipients.
- Recipients of an organ from an non-heart beating donor.
- Patients receiving a second kidney allograft if the first allograft was
- Functional for less than three years
- Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Novartis Investigative Site
Birmingham, Alabama, 35233, United States
Novartis Investigative Site
Aurora, Colorado, 80045, United States
Novartis Investigative Site
Ann Arbor, Michigan, 48109, United States
Novartis Investigative Site
Detroit, Michigan, 48202-2689, United States
Novartis Investigative Site
Cincinnati, Ohio, 45219, United States
Novartis Investigative Site
Cincinnati, Ohio, 45267-0585, United States
Novartis Investigative Site
Madison, Wisconsin, 53792, United States
Novartis Investigative Site
Corrientes, W3400, Argentina
Novartis Investigative Site
Córdoba, X5016KEH, Argentina
Novartis Investigative Site
Córdoba, X5022CPU, Argentina
Novartis Investigative Site
Camperdown, New South Wales, 2050, Australia
Novartis Investigative Site
Woolloongabba, Queensland, 4102, Australia
Novartis Investigative Site
Adelaide, South Australia, 5000, Australia
Novartis Investigative Site
Melbourne, Victoria, 3050, Australia
Novartis Investigative Site
Brussels, 1070, Belgium
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 04023-900, Brazil
Novartis Investigative Site
Vancouver, British Columbia, V6Z 1Y6, Canada
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Aarhus, 8000 C, Denmark
Novartis Investigative Site
Berlin, 10098, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Cologne, 51109, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hanover, 30625, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Regensburg, 93053, Germany
Novartis Investigative Site
Budapest, 1082, Hungary
Novartis Investigative Site
Szeged, 6720, Hungary
Novartis Investigative Site
Rotterdam, 3015 CE, Netherlands
Novartis Investigative Site
Coimbra, 3000-075, Portugal
Novartis Investigative Site
Lisbon, 1069-166, Portugal
Novartis Investigative Site
Porto, 4099-001, Portugal
Novartis Investigative Site
Seoul, Korea, 120-752, South Korea
Novartis Investigative Site
Seoul, Korea, 138-736, South Korea
Novartis Investigative Site
Gothenburg, SE-413 45, Sweden
Novartis Investigative Site
Stockholm, 141 86, Sweden
Novartis Investigative Site
Uppsala, 751 85, Sweden
Novartis Investigative Site
Glasgow, G11 6NT, United Kingdom
Novartis Investigative Site
Leicester, LE5 4PW, United Kingdom
Novartis Investigative Site
Manchester, M13 9WL, United Kingdom
Related Publications (1)
Russ GR, Tedesco-Silva H, Kuypers DR, Cohney S, Langer RM, Witzke O, Eris J, Sommerer C, von Zur-Muhlen B, Woodle ES, Gill J, Ng J, Klupp J, Chodoff L, Budde K. Efficacy of sotrastaurin plus tacrolimus after de novo kidney transplantation: randomized, phase II trial results. Am J Transplant. 2013 Jul;13(7):1746-56. doi: 10.1111/ajt.12251. Epub 2013 May 13.
PMID: 23668931RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharmceuticals
Novartis Pharmceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 8, 2010
Study Start
December 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 22, 2020
Record last verified: 2016-11