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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

NCT ID: NCT00555789

Last Updated: 2020-12-17

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

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This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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kidney transplantation rejection AEB071 tacrolimus mycophenolic acid immunosuppression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

mycophenolic and tacrolimus

Group Type ACTIVE_COMPARATOR

mycophenolic plus tacrolimus

Intervention Type DRUG

720mg b.i.d. 2yrs

2

mycophenolic and tacrolimus

Group Type EXPERIMENTAL

AEB071

Intervention Type DRUG

200mg oral b.i.d.

Interventions

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AEB071

200mg oral b.i.d.

Intervention Type DRUG

mycophenolic plus tacrolimus

720mg b.i.d. 2yrs

Intervention Type DRUG

Other Intervention Names

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mycophenolic plus tacrolimus

Eligibility Criteria

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Inclusion Criteria

* Participation in core study CAEB071A2203
* The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.
* Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
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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Novartis Investigative Site

San Francisco, California, United States

Site Status

Novartis Investigative Site

Madison, Wisconsin, United States

Site Status

Novartis Investigative Site

Halifax, , Canada

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Novartis Investigative Site

Le Kremlin-Bicêtre, , France

Site Status

Novartis Investigative Site

Nantes, , France

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Novartis Investigative Site

Paris, , France

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Novartis Investigative Site

Toulouse, , France

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Cologne, , Germany

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Novartis Investigative Site

Essen, , Germany

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Novartis Investigative Site

Hanover, , Germany

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Novartis Investigative Site

Heidelberg, , Germany

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Novartis Investigative Site

Bologna, , Italy

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Novartis Investigative Site

Florence, , Italy

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Novartis Investigative Site

Padua, , Italy

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Novartis Investigative Site

Llobregat, , Spain

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Novartis Investigative Site

Madrid, , Spain

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Novartis Investigative Site

Málaga, , Spain

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Novartis Investigative Site

Valencia, , Spain

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Novartis Investigative Site

Basel, , Switzerland

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Novartis Investigative Site

Bern, , Switzerland

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Novartis Investigative Site

Zurich, , Switzerland

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Novartis Investigative Site

Cardiff, , United Kingdom

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Novartis Investigative Site

Glasgow, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Countries

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United States Canada France Germany Italy Spain Switzerland United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2800

Results for CAEB071A2203E1 on the Novartis clinical trials website

Other Identifiers

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AEB071A2203E1

Identifier Type: -

Identifier Source: org_study_id