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Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

NCT ID: NCT01064791

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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Renal transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

Group Type EXPERIMENTAL

sotrastaurin (Dose 1) + tacrolimus + standard of care medications

Intervention Type DRUG

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

Arm 2

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

Group Type EXPERIMENTAL

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

Intervention Type DRUG

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

Arm 3

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

Group Type EXPERIMENTAL

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

Intervention Type DRUG

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

Arm 4

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Group Type ACTIVE_COMPARATOR

mycophenolic acid + tacrolimus + standard of care medications

Intervention Type DRUG

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Interventions

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sotrastaurin (Dose 1) + tacrolimus + standard of care medications

sotrastaurin (100mg bid) + tacrolimus + standard of care medications

Intervention Type DRUG

sotrastaurin (Dose 2) + tacrolimus + standard of care medications

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

Intervention Type DRUG

sotrastaurin (Dose 3) + tacrolimus + standard of care medications

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

Intervention Type DRUG

mycophenolic acid + tacrolimus + standard of care medications

mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Aurora, Colorado, United States

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Novartis Investigative Site

Ann Arbor, Michigan, United States

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Novartis Investigative Site

Detroit, Michigan, United States

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Novartis Investigative Site

Cincinnati, Ohio, United States

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Novartis Investigative Site

Cincinnati, Ohio, United States

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Novartis Investigative Site

Madison, Wisconsin, United States

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Novartis Investigative Site

Corrientes, , Argentina

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Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

Camperdown, New South Wales, Australia

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Novartis Investigative Site

Woolloongabba, Queensland, Australia

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Novartis Investigative Site

Adelaide, South Australia, Australia

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Novartis Investigative Site

Melbourne, Victoria, Australia

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Novartis Investigative Site

Vancouver, British Columbia, Canada

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Novartis Investigative Site

Cali, , Colombia

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Novartis Investigative Site

Aarhus, , Denmark

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Cologne, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Novartis Investigative Site

Hanover, , Germany

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Novartis Investigative Site

Heidelberg, , Germany

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Novartis Investigative Site

Regensburg, , Germany

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Novartis Investigative Site

Budapest, , Hungary

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Novartis Investigative Site

Szeged, , Hungary

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Novartis Investigative Site

Rotterdam, , Netherlands

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Novartis Investigative Site

Coimbra, , Portugal

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Novartis Investigative Site

Lisbon, , Portugal

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Novartis Investigative Site

Porto, , Portugal

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Novartis Investigative Site

Seoul, Korea, South Korea

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Novartis Investigative Site

Seoul, Korea, South Korea

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Novartis Investigative Site

Gothenburg, , Sweden

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Novartis Investigative Site

Stockholm, , Sweden

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Novartis Investigative Site

Uppsala, , Sweden

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Novartis Investigative Site

Glasgow, , United Kingdom

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Novartis Investigative Site

Leicester, , United Kingdom

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Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Colombia Denmark Germany Hungary Netherlands Portugal South Korea Sweden United Kingdom

References

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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.

Reference Type RESULT
PMID: 23668931 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10063

Novartis Results on CAEB071A2214 from the Novartis Clinical Trials Website

Other Identifiers

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2009-015456-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAEB071A2214

Identifier Type: -

Identifier Source: org_study_id