NCT01128335|CompletedPhase 2

Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

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

Novartis Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

CAEB071B22012007-001776-36

Study Type

interventional

Target

200

Locations

12 countries

Sites

Timeline

RegisteredMay 2010

StartedApr 2010

CompletionJul 2012

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 liver transplantation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2010

Geographic Reach

12 countries

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

April 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

Last Updated

December 22, 2020

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

May 20, 2010

Last Update Submit

December 15, 2020

Conditions

Liver Transplantation

Keywords

Liver transplantationHCV-negative recipientdeceased donorsotrastaurinoran transplantationtacrolimus

Outcome Measures

Primary Outcomes (1)

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.
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).
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.
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
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).
Months 3, 6, 12, 24

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

MMF(1000mg bid) + tacrolimus + standard of care medications

Drug: MMF(1000mg bid) + tacrolimus + standard of care medications

Arm 2

EXPERIMENTAL

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Arm 3

EXPERIMENTAL

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Arm 4

EXPERIMENTAL

sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Interventions

MMF(1000mg bid) + tacrolimus + standard of care medicationsDRUG

MMF(1000mg bid) + tacrolimus + standard of care medications

Arm 1

sotrastaurin (200mg bid) + tacrolimus + standard of care medicationsDRUG

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Arm 2

sotrastaurin (300 mg bid) + tacrolimus + standard of care medicationsDRUG

sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Arm 4

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartis Pharmaceuticalslead

Study Sites (39)

Novartis Investigative Site

Los Angeles, California, 90095, United States

Location

Novartis Investigative Site

San Francisco, California, 94143, United States

Location

Novartis Investigative Site

Detroit, Michigan, 48202-2689, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

Location

Novartis Investigative Site

Rochester, Minnesota, 55905, United States

Location

Novartis Investigative Site

Cincinnati, Ohio, 45219, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

CABA, Buenos Aires, C1118AAT, Argentina

Location

Novartis Investigative Site

CABA, Buenos Aires, C1181ACH, Argentina

Location

Novartis Investigative Site

San Martín, Buenos Aires, C1107BEA, Argentina

Location

Novartis Investigative Site

Innsbruck, A-6020, Austria

Location

Novartis Investigative Site

Vienna, A-1090, Austria

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

London, Ontario, N6A 4G5, Canada

Location

Novartis Investigative Site

Prague, Czech Republic, 140 21, Czechia

Location

Novartis Investigative Site

Brno, 656 91, Czechia

Location

Novartis Investigative Site

HUS, 00029, Finland

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Chambray-lès-Tours, 37044, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Paris, 75012, France

Location

Novartis Investigative Site

Strasbourg, 67098, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Pisa, PI, 56124, Italy

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

A Coruña, Galicia, 15006, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

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.
PMID: 25677074RESULT

MeSH Terms

Interventions

BID protein, humanTacrolimussotrastaurin

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

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

May 20, 2010

First Posted

May 21, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 22, 2020

Record last verified: 2016-11

Locations

ES(4)BE(2)CZ(2)IT(3)DE(6)FI(1)US(8)AR(3)FR(6)AU(2)CA(1)CH(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

Arm 1

Arm 2

Arm 3

Arm 4

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (39)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations