AzTrials
AzTrials

Renal TransplantationPhase 2NCT01064791

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

A Phase 2 study of Renal Transplantation, run by Novartis Pharmaceuticals at 44 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 renal transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
44 sitesin 15 countries
Study dates
Dec 2009to Aug 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 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.

Who cannot join

  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

44 sites in 15 countries.

44 sites in 15 countries

Germany8 sites

  • Novartis Investigative Site

    Berlin, 10098

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Cologne, 51109

  • 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

Other trials in Germany

United States7 sites

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48109

  • Novartis Investigative Site

    Aurora, Colorado, 80045

  • Novartis Investigative Site

    Birmingham, Alabama, 35233

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Cincinnati, Ohio, 45267-0585

  • Novartis Investigative Site

    Detroit, Michigan, 48202-2689

  • Novartis Investigative Site

    Madison, Wisconsin, 53792

Other trials in United States

Australia4 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Melbourne, Victoria, 3050

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Argentina3 sites

  • Novartis Investigative Site

    Córdoba, X5016KEH

  • Novartis Investigative Site

    Córdoba, X5022CPU

  • Novartis Investigative Site

    Corrientes, W3400

Other trials in Argentina

Belgium3 sites

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Portugal3 sites

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Lisbon, 1069-166

  • Novartis Investigative Site

    Porto, 4099-001

Other trials in Portugal

Sweden3 sites

  • Novartis Investigative Site

    Gothenburg, SE-413 45

  • Novartis Investigative Site

    Stockholm, 141 86

  • Novartis Investigative Site

    Uppsala, 751 85

Other trials in Sweden

United Kingdom3 sites

  • Novartis Investigative Site

    Glasgow, G11 6NT

  • Novartis Investigative Site

    Leicester, LE5 4PW

  • Novartis Investigative Site

    Manchester, M13 9WL

Other trials in United Kingdom

Brazil2 sites

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

Other trials in Brazil

Hungary2 sites

  • Novartis Investigative Site

    Budapest, 1082

  • Novartis Investigative Site

    Szeged, 6720

Other trials in Hungary

South Korea2 sites

  • Novartis Investigative Site

    Seoul, Korea, 120-752

  • Novartis Investigative Site

    Seoul, Korea, 138-736

Other trials in South Korea

Canada1 site

  • Novartis Investigative Site

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Colombia1 site

  • Novartis Investigative Site

    Cali

Other trials in Colombia

Denmark1 site

  • Novartis Investigative Site

    Aarhus, 8000 C

Other trials in Denmark

Netherlands1 site

  • Novartis Investigative Site

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: 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

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.

Being tested
sotrastaurin (Dose 1) + tacrolimus + standard of care medications, sotrastaurin (Dose 2) + tacrolimus + standard of care medications, sotrastaurin (Dose 3) + tacrolimus + standard of care medications, mycophenolic acid + tacrolimus + standard of care medications
Keywords
Renal transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sotrastaurin (Dose 1) + tacrolimus + standard of care medicationsDrug

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

  • sotrastaurin (Dose 2) + tacrolimus + standard of care medicationsDrug

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

  • sotrastaurin (Dose 3) + tacrolimus + standard of care medicationsDrug

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

  • mycophenolic acid + tacrolimus + standard of care medicationsDrug

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

Study groups in NCT01064791
Study groupRoleWhat they receive
Arm 1Experimentalsotrastaurin (100mg bid) + tacrolimus + standard of care medications
Receives: Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications
Arm 2Experimentalsotrastaurin (200mg bid) + tacrolimus + standard of care medications
Receives: Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications
Arm 3Experimentalsotrastaurin (300mg bid) + tacrolimus + standard of care medications
Receives: Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications
Arm 4Active comparatormycophenolic acid (720mg bid) + tacrolimus + standard of care medications
Receives: Drug: mycophenolic acid + tacrolimus + standard of care medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Month 6

Secondary outcomes (4)

  1. Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)

    Measured: Months 6, 12, 24, and 36

  2. 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).

    Measured: Months 12, 24, and 36

  3. Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).

    Measured: Months 6, 12, 24, and 36

  4. Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).

    Measured: Months 6, 12, 24, and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064791
Sponsor's protocol ID
CAEB071A2214
Other IDs
2009-015456-14, 2009
Status last verified
Nov 2016
First submitted
2 Feb 2010
Last updated
22 Dec 2020
Results posted
No

Publications

  • 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.

    PubMed 23668931

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Renal Transplantation, run by Novartis Pharmaceuticals at 44 sites in 15 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 6 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 44 sites in Germany, United States, Australia, Argentina, Belgium and 10 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?

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). (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 NCT01064791, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in