NCT00820911

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
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
16 countries

27 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

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
3.5 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

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

3.8 years

First QC Date

January 9, 2009

Last Update Submit

February 22, 2017

Conditions

Kidney Transplantation

Keywords

Kidney transplantAEB071

Outcome Measures

Primary Outcomes (1)

  • renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula

    at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary Outcomes (1)

  • efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up

    at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Study Arms (3)

cyclosporine (reduced exposure) / everolimus

ACTIVE COMPARATOR
Drug: cyclosporine (reduced exposure) / everolimus

AEB071 300 mg b.i.d. / everolimus

EXPERIMENTAL
Drug: AEB071 300 mg b.i.d. / everolimus

AEB071 200 mg b.i.d. / everolimus

EXPERIMENTAL
Drug: AEB071 200 mg b.i.d. / everolimus

Interventions

cyclosporine (reduced exposure) / everolimusDRUG

twice daily

cyclosporine (reduced exposure) / everolimus
AEB071 300 mg b.i.d. / everolimusDRUG

twice daily

AEB071 300 mg b.i.d. / everolimus
AEB071 200 mg b.i.d. / everolimusDRUG

twice daily

AEB071 200 mg b.i.d. / everolimus

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has been maintained on study drug for 12 months in the core study

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Novartis Investigative Site

San Martín, Buenos Aires, C1107BEA, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5022CPU, Argentina

Location

Novartis Investigative Site

Camperdown, New South Wales, 2050, Australia

Location

Novartis Investigative Site

Woodville, South Australia, 5011, Australia

Location

Novartis Investigative Site

Clayton, Victoria, 3168, Australia

Location

Novartis Investigative Site

Innsbruck, A-6020, Austria

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Cali, Colombia

Location

Novartis Investigative Site

Prague, 140 00, Czechia

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Nantes, 44035, France

Location

Novartis Investigative Site

Toulouse, 31054, France

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Milan, MI, 20122, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Novartis Investigative Site

Oslo, 0424, Norway

Location

Novartis Investigative Site

Singapore, Singapore, 119074, Singapore

Location

Novartis Investigative Site

Košice, Slovak Republic, 041 90, Slovakia

Location

Novartis Investigative Site

Banská Bystrica, Slovakia, 975 17, Slovakia

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28034, Spain

Location

Novartis Investigative Site

Zurich, Switzerland, 8091, Switzerland

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

MeSH Terms

Interventions

CyclosporineEverolimussotrastaurin

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsSirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    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

January 9, 2009

First Posted

January 12, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

CZ(1)FR(3)AR(2)CO(2)SG(1)DE(2)ES(2)TW(1)CH(1)BE(1)AU(3)SL(2)NO(1)BR(2)NL(1)IT(2)