To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.

NCT ID: NCT00296361

Last Updated: 2014-09-01

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

PHASE3

Total Enrollment

634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

Detailed Description

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This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

immunosuppression

2

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

immunosuppression

Interventions

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Tacrolimus

immunosuppression

Intervention Type DRUG

Other Intervention Names

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Prograf, FK506

Eligibility Criteria

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Inclusion Criteria

* Patients between 18 and 60 years of age and having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.

Exclusion Criteria

* Patient has a high immunological risk
* Cold ischemia time greater than 30 hours
* Patient has significant liver disease
* Patient has severe hypercholesterolaemia
* Patient is allergic or intolerant to study medication
* Patient requires ongoing dosing with corticosteroids.
* Patient or donor is known to be HIV positive
* Patient with malignancy or history of malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Physician

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Nedlands, , Australia

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Perth, , Australia

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Linz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Olomouc, , Czechia

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Ostrava, , Czechia

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Amiens, , France

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Brest, , France

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Dijon, , France

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Limoges, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Toulouse, , France

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Aachen, , Germany

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Bochum, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Freiburg im Breisgau, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hannoversch Münden, , Germany

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Hanover, , Germany

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Münster, , Germany

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Regensburg, , Germany

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Rostock, , Germany

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Debrecen, , Hungary

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Milan, , Italy

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Napoli, , Italy

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Rotterdam, , Netherlands

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Gdansk, , Poland

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Krakow, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Alicante, , Spain

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Badalona-Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Cadiz, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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Gothenburg, , Sweden

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London, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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Australia Austria Belgium Czechia France Germany Hungary Italy Netherlands Poland Romania Spain Sweden United Kingdom

Related Links

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Other Identifiers

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FG-506-02-40

Identifier Type: -

Identifier Source: org_study_id

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