NCT00504543

Brief Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Geographic Reach
16 countries

24 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

Study Start

First participant enrolled

July 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

July 19, 2007

Last Update Submit

November 16, 2016

Conditions

Kidney Transplantation

Keywords

Kidney transplant, AEB071

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.

    12 months

Secondary Outcomes (1)

  • Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK

    12 months

Study Arms (3)

Neoral

ACTIVE COMPARATOR
Drug: Neoral

AEB071 high dose with Cetican reduced dose

ACTIVE COMPARATOR
Drug: AEB071Drug: Certican

AEB071 low dose with Cetican standard dose

ACTIVE COMPARATOR
Drug: AEB071Drug: Certican

Interventions

AEB071DRUG

oral, twice daily

AEB071 high dose with Cetican reduced doseAEB071 low dose with Cetican standard dose
CerticanDRUG

twice daily

AEB071 high dose with Cetican reduced doseAEB071 low dose with Cetican standard dose
NeoralDRUG

twice daily

Neoral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients 18 years or older
  • Recipients of first kidney transplant from a deceased or living not related donor

You may not qualify if:

  • Need for medication prohibited in the study
  • Patients with heart disease (own or family history)
  • Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
  • Patients with high immunological risks
  • Patients with a history of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Argentina

Buenos Aires, 1107, Argentina

Location

Novartis Investigative Site

Buenos Aires, 1425, Argentina

Location

Australia

Sydney, 2050, Australia

Location

Australia

Sydney, 5011, Australia

Location

Austria

Innsbruck, 6020, Austria

Location

Austria

Wein, 1090, Austria

Location

Belgium

Ghent, 9000, Belgium

Location

Brazil

São Paulo, 04038-002, Brazil

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Cali, Colombia

Location

Czech Republic

Prague, 14021, Czechia

Location

France

Lille, 59037, France

Location

France

Toulouse, 31055, France

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Italy

Milan, 20100, Italy

Location

Italy

Milan, 20122, Italy

Location

Netherlands

Rotterdam, 3000CA, Netherlands

Location

Norway

Oslo, 0027, Norway

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Banská Bystrica, 97517, Slovakia

Location

Novartis Investigative Site

Košice, 04066, Slovakia

Location

Spain

Barcelona, 08024, Spain

Location

Spain

Madrid, 28034, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Taipie, 10002, Taiwan

Location

Related Publications (1)

  • Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.

    PMID: 23659755RESULT

MeSH Terms

Interventions

sotrastaurinEverolimusCyclosporine

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 20, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

SL(2)AU(2)CH(1)TW(1)CO(2)CZ(1)BE(1)DE(2)FR(2)BR(1)ES(2)AR(2)IT(2)SG(1)NL(1)NO(1)