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Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation (Conversion)

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ClinicalTrials.gov Identifier: NCT02105155
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The best period for the conversion from Prograf (tacrolimus administered twice daily) to Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this prospective, randomized, multicenter trial is to prove the non-inferiority of the early conversion (at D7) versus the conversion at D90 after liver transplantation. The primary objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6 first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies will be compared in terms of superiority. 250 patients will be included. Three ancillary studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in all patients

Condition or disease Intervention/treatment Phase
Immunosuppression After Liver Transplantation Drug: Conversion at day 7 ± 3 Prograf® to Advagraf® Drug: Conversion at day 90±5 Prograf® to Advagraf® Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-inferiority and Tolerance of Conversion From Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation
Actual Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 17, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Conversion at day 7 ± 3
Conversion from Prograf to Advagraf at D7 ± 3
Drug: Conversion at day 7 ± 3 Prograf® to Advagraf®
Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 7±3

Active Comparator: Conversion at day 90±5
Conversion from Prograf to Advagraf at 90±5
Drug: Conversion at day 90±5 Prograf® to Advagraf®
Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 90±5




Primary Outcome Measures :
  1. First episode of acute rejection during the first 6 months [ Time Frame: 6 months ]
    First episode of acute rejection during the first 6 months


Secondary Outcome Measures :
  1. Renal function [ Time Frame: 6 months ]
    Glomerular filtration rate using MDRD4

  2. Adverse effects [ Time Frame: 6 months ]
    All side effects

  3. Severity of acute rejection [ Time Frame: 6 months ]
    Histological severity of acute rejection using the Banff 2007 criteria



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • 18 to 75 years
  • First liver transplantation
  • No contra-indication to tacrolimus, mycophenolate mofetil or steroids
  • Informed consent signed
  • French Health Assurance

Exclusion Criteria :

  • Combined transplantation
  • Severe uncontrolled infection
  • Hypersensitivity to tacrolimus or its excipients, to other macrolides, to mycophenolate mofetil or its excipients
  • Pregnant or lactating woman, or women of childbearing potential without adequate method of contraception
  • Cancer or pasthistory of cancer other than basal or squamous cell carcinoma or hepatocellular carcinoma suitable for liver transplantation
  • Patients with renal impairment where GFR is less than 30ml/min
  • HIV positivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105155


Locations
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France
Hôpital Pitié Salpêtrière unité médicale de transplantion hépatique
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yvon Calmus, MD, PhD Assistance Publique

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02105155     History of Changes
Other Study ID Numbers: P 120907
HAO 2012 ( Other Identifier: Assistance Publique )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver transplantation,
Conversion (Prograf® to Advagraf®),
Prograf® ,
Advagraf® ,
acute rejection,
GFR
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action