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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplantation

Intervention: Prograf® (Drug); Advagraf® (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Astellas Pharma S.A.S.

Official(s) and/or principal investigator(s):
Medical and Scientific Affairs Manager, Transplantation, Study Director, Affiliation: Astellas Pharma S.A.S.

Overall contact:
Medical Dept Clinical Operations Dept, Phone: +31 (0)71 545 5050, Email: Astellas.registration@astellas.com

Summary

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).

Clinical Details

Official title: French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf) to the Once Per Day Form (Advagraf)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)

Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion

Number of additional visits that the doctor considers to be due to the conversion (if applicable)

Secondary outcome:

Reasons for the conversion

Profile of the patients in both groups

Time to reach steady state

Dose ratio at steady state

The intra-patient variability (IPV) of tacrolimus

Latest available laboratory data with Prograf® before conversion and with Advagraf®

Compliance with the treatment at conversion and at 1 year post-conversion

The quality of life of the patient at conversion and at 1 year post-conversion

Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient

Occurrence of adverse effects

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Medical Dept Clinical Operations Dept, Phone: +31 (0)71 545 5050, Email: Astellas.registration@astellas.com

CHU Amiens Groupe Hospitalier Sud, Amiens, France; Recruiting

CHU Angers, Angers, France; Active, not recruiting

Hôpital Jean Minjoz, Besancon, France; Recruiting

Hôpital de la Cavale Blanche, Brest, France; Recruiting

Hôpital Ciemenceau, Caen, France; Recruiting

Hôpital Gabriel Montpied, Clermond-Ferrand, France; Recruiting

Hôpital Henri Mondor, Creteil, France; Recruiting

Hôpital du BOCAGE, Dijon, France; Active, not recruiting

Hôpital Michallon-CHU Nord, Grenoble, France; Withdrawn

Hôpital Bicetre, Le Krémlin-Bicêtre, France; Recruiting

Hôpital Claude Huriez, Lille, France; Recruiting

Hôpital Dupuytren CHU Limoges, Limoges, France; Recruiting

Hôpital Edouard Herriot, Lyon 3, France; Recruiting

Hôpital de la Conception, Marseille, France; Recruiting

Hôpital Lapeyronie, Montpellier, France; Recruiting

Hôpitaux de Brabois Adulte, Nancy, France; Recruiting

Hotel Dieu CHU de Nantes, Nantes, France; Recruiting

Hopital de L'Archet 2, Nice, France; Recruiting

Hôpital Bichat, Paris 10, France; Recruiting

Hôpital Saint-Louis, Paris 10, France; Recruiting

Hôpital Européen G. Pompidou, Paris 15, France; Withdrawn

Hôpital Necker, Paris 15, France; Withdrawn

Hôpital de la Pitié Salpêtrière, Paris Cedex 13 75013, France; Recruiting

CHRU Pontchaillou, Rennes, France; Recruiting

Hôpital de Bois Guillaume CHU de Rouen, Rouen, France; Recruiting

Hôpital Nord, Saint Etienne, France; Recruiting

Nouvel Hopital Civil Hôpitaux Universitaires de Strasbourg, Strasbourg, France; Recruiting

Hôpital Foch, Suresnes, France; Recruiting

Hôpital de Rangueil, Toulouse, France; Recruiting

Hôpital Bretonneau, Tours, France; Recruiting

Additional Information

Starting date: July 2014
Last updated: July 1, 2015

Page last updated: August 23, 2015

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