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Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

NCT ID: NCT00820911

Last Updated: 2017-02-24

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

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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

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Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

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Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

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24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

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Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

NCT00492869

Kidney Transplantation
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Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cyclosporine (reduced exposure) / everolimus

Group Type ACTIVE_COMPARATOR

cyclosporine (reduced exposure) / everolimus

Intervention Type DRUG

twice daily

AEB071 300 mg b.i.d. / everolimus

Group Type EXPERIMENTAL

AEB071 300 mg b.i.d. / everolimus

Intervention Type DRUG

twice daily

AEB071 200 mg b.i.d. / everolimus

Group Type EXPERIMENTAL

AEB071 200 mg b.i.d. / everolimus

Intervention Type DRUG

twice daily

Interventions

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cyclosporine (reduced exposure) / everolimus

twice daily

Intervention Type DRUG

AEB071 300 mg b.i.d. / everolimus

twice daily

Intervention Type DRUG

AEB071 200 mg b.i.d. / everolimus

twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Locations

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Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Site Status

Novartis Investigative Site

Camperdown, New South Wales, Australia

Site Status

Novartis Investigative Site

Woodville, South Australia, Australia

Site Status

Novartis Investigative Site

Clayton, Victoria, Australia

Site Status

Novartis Investigative Site

Innsbruck, , Austria

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

Bogotá, , Colombia

Site Status

Novartis Investigative Site

Cali, , Colombia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Brest, , France

Site Status

Novartis Investigative Site

Nantes, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Oslo, , Norway

Site Status

Novartis Investigative Site

Singapore, Singapore, Singapore

Site Status

Novartis Investigative Site

Košice, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Banská Bystrica, Slovakia, Slovakia

Site Status

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Novartis Investigative Site

Madrid, Madrid, Spain

Site Status

Novartis Investigative Site

Zurich, Switzerland, Switzerland

Site Status

Novartis Investigative Site

Taipei, Taiwan, Taiwan

Site Status

Countries

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Argentina Australia Austria Belgium Brazil Colombia Czechia France Germany Italy Netherlands Norway Singapore Slovakia Spain Switzerland Taiwan

Other Identifiers

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2008-000531-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAEB071A2206E1

Identifier Type: -

Identifier Source: org_study_id

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