A Study to Evaluate FK778 in Kidney Transplant Patients

NCT ID: NCT00189735

Last Updated: 2008-04-17

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-10-31

Brief Summary

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A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

Detailed Description

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Conditions

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Kidney Transplantation Renal Transplantation Transplantation, Renal Transplantation, Kidney Grafting, Kidney

Keywords

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Treatment Efficacy Treatment Effectiveness Anti-rejection therapy Immunosuppression Antirejection Malononitrilamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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FK778

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
* Patient has been fully informed.

Exclusion Criteria

* Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
* Patient has significant liver disease.
* Cold ischemia time of the donor kidney \>28 hours.
* Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
* Patient has previously received or is receiving an organ transplant other than kidney.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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H. H. Neumayer

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik Charité

Locations

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Innsbruck, , Austria

Site Status

Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Prague, , Czechia

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Brest, , France

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Créteil, , France

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Grenoble, , France

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Le Kremlin-Bicêtre, , France

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Montpellier, , France

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Rennes, , France

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Saint-Etienne, , France

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Toulouse, , France

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Berlin, , Germany

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Berlin, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Halle, , Germany

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München, , Germany

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Regensburg, , Germany

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Padua, , Italy

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Roma, , Italy

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Torino, , Italy

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Maastricht, , Netherlands

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Bydgoszcz, , Poland

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Szczecin, , Poland

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Santander, , Spain

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Valencia, , Spain

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Uppsala, , Sweden

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Zurich, , Switzerland

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Manchester, , United Kingdom

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Countries

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Austria Belgium Czechia France Germany Italy Netherlands Poland Spain Sweden Switzerland United Kingdom

Other Identifiers

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FG-778-02-60

Identifier Type: -

Identifier Source: org_study_id