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

NCT ID: NCT00504543

Last Updated: 2016-11-18

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

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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Kidney transplant, AEB071

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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Neoral

Group Type ACTIVE_COMPARATOR

Neoral

Intervention Type DRUG

twice daily

AEB071 high dose with Cetican reduced dose

Group Type ACTIVE_COMPARATOR

AEB071

Intervention Type DRUG

oral, twice daily

Certican

Intervention Type DRUG

twice daily

AEB071 low dose with Cetican standard dose

Group Type ACTIVE_COMPARATOR

AEB071

Intervention Type DRUG

oral, twice daily

Certican

Intervention Type DRUG

twice daily

Interventions

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AEB071

oral, twice daily

Intervention Type DRUG

Certican

twice daily

Intervention Type DRUG

Neoral

twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
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

Role: STUDY_DIRECTOR

Novartis

Locations

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Argentina

Buenos Aires, , Argentina

Site Status

Novartis Investigative Site

Buenos Aires, , Argentina

Site Status

Australia

Sydney, , Australia

Site Status

Australia

Sydney, , Australia

Site Status

Austria

Innsbruck, , Austria

Site Status

Austria

Wein, , Austria

Site Status

Belgium

Ghent, , Belgium

Site Status

Brazil

São Paulo, , Brazil

Site Status

Novartis Investigative Site

Bogotá, , Colombia

Site Status

Novartis Investigative Site

Cali, , Colombia

Site Status

Czech Republic

Prague, , Czechia

Site Status

France

Lille, , France

Site Status

France

Toulouse, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Italy

Milan, , Italy

Site Status

Italy

Milan, , Italy

Site Status

Netherlands

Rotterdam, , Netherlands

Site Status

Norway

Oslo, , Norway

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Banská Bystrica, , Slovakia

Site Status

Novartis Investigative Site

Košice, , Slovakia

Site Status

Spain

Barcelona, , Spain

Site Status

Spain

Madrid, , Spain

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Novartis Investigative Site

Taipie, , 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

References

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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.

Reference Type RESULT
PMID: 23659755 (View on PubMed)

Other Identifiers

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CAEB071A2206

Identifier Type: -

Identifier Source: org_study_id