A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)

NCT ID: NCT02147938

Last Updated: 2024-11-01

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

Total Enrollment

578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-17

Study Completion Date

2017-05-15

Brief Summary

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Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.

Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1: early conversion from Prograf® to Advagraf®

patients converted during the first 6 months post-transplantation

Tacrolimus

Intervention Type DRUG

oral

2: late conversion from Prograf® to Advagraf®

patients converted between 6 and 12 months post-transplantation

Tacrolimus

Intervention Type DRUG

oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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Advagraf® Prograf® FK506

Eligibility Criteria

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Inclusion Criteria

* Renal transplant patient for less than one year
* Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor

Exclusion Criteria

* Patient participating in an interventional clinical trial at the time of inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma S.A.S.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical and Scientific Affairs Manager, Transplantation

Role: STUDY_DIRECTOR

Astellas Pharma S.A.S.

Locations

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Amiens, , France

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Angers, , France

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Besançon, , France

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Brest, , France

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Caen, , France

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Clermond-Ferrand, , France

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Créteil, , France

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Dijon, , France

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Le Krémlin-Bicêtre, , France

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Lille, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nancy, , France

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Nantes, , France

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Nice, , France

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Paris, , France

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Poitiers, , France

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Rennes, , France

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Rouen, , France

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Saint-Etienne, , France

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Strasbourg, , France

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Suresnes, , France

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Toulouse, , France

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Tours, , France

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Countries

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France

Other Identifiers

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FR-ADV-NI-003

Identifier Type: -

Identifier Source: org_study_id

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