Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
18
transplantation
1- To demonstrate, in liver transplant recipients on ENVARSUS®, that an immunosuppressive strategy based on MMF QD started at M6 post-transplantation is not inferior to MMF administered BID, in terms of incidence of treatment failure (defined by a composite endpoint) at M18 after transplantation 2- To demonstrate, in l…
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Limoges
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 15 Apr 2025 → ongoing
- Decision date (initial)
- 2024-05-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- TRAJAN SCIENTIFIC AND MEDICAL · CHIESI
External identifiers
- EU CT number
- 2023-506601-19-00
- WHO UTN
- U1111-1303-2099
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
1- To demonstrate, in liver transplant recipients on ENVARSUS®, that an immunosuppressive strategy based on MMF QD started at M6 post-transplantation is not inferior to MMF administered BID, in terms of incidence of treatment failure (defined by a composite endpoint) at M18 after transplantation
2- To demonstrate, in liver transplant recipients, that LCP-tacrolimus (ENVARSUS®) is equivalent to XR-tacrolimus (ADVAGRAF®) QD, in terms of incidence of treatment failure (defined by a composite endpoint) at the end of sixth month after transplantation
Secondary objectives 6
- To evaluate, 18 months after liver transplantation, if LCP-tacrolimus (ENVARSUS®) is equivalent to XR-tacrolimus (ADVAGRAF®) QD, in terms of incidence of treatment failure (see primary objective).
- To compare, between the four arms, at 6 and 18 months after transplantation, the incidence of: a. Death b. Graft loss c. Biopsy-proven acute rejection, with a rejection activity index score ≥4 according to the Banff criteria
- To compare, 18 months after liver transplantation, the impact of LCP-tacrolimus (ENVARSUS®) vs. XR-tacrolimus (ADVAGRAF®) QD on: a. Adherence, b. Health-related quality of life.
- To compare the incidence of adverse events in patients on LCP-tacrolimus (ENVARSUS®) vs. XR-tacrolimus (ADVAGRAF®) over 18 months after liver transplantation. Adverse events of interest will be: gastro-intestinal disorders, CMV infections, neutropenia, sepsis, renal function impairment, new onset post-transplant diabetes mellitus, hypertension, hyperlipidemia, tremor.
- To evaluate, 18 months after liver transplantation, the benefits of switching from MMF BID to MMF QD in terms of: a. Adherence, b. Health-related quality of life, c. Adverse events of interest (see secondary objective #2).
- To compare, between the four arms and at each post-transplantation period: a. The average daily exposure (AUC0-24h) to tacrolimus and mycophenolic acid (MPA), b. Tacrolimus C0/dose and AUC0-24h/dose, c. MPA AUC0-24h/dose.
Conditions and MedDRA coding
transplantation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. Male and female patients, aged 18 and older
- 2. Recipients of a first liver allograft from a deceased donor
- 3. Transplanted for less than four weeks at enrolment
- 4. Without inter-current progressive life-threatening or graft-threatening disease
- 5. Having signed a written informed consent for their participation in the study.
- 6. Affiliated to, or beneficiary of, a social security regimen
Exclusion criteria 12
- 1. Recipients of a split-liver transplantation
- 11. Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.
- 12. Patients already enrolled in another clinical study evaluating drugs or therapeutic strategies.
- 2. Recipients of any transplanted organ other than the liver
- 3. Patient who has undergone colon resection
- 4. Patients under legal protection (guardianship, curatorship)
- 5. Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.
- 7. Patients in whom everolimus-based CNI minimization is anticipated
- 8. Pregnant or lactating women without efficient contraceptive method (based on declaration)
- 9. Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence during treatment by CELLCEPT and for 6 weeks after the end of CELLCEPT administration
- 10. Sexually active men or their female partner without any effective contraception during treatment by CELLCEPT and for at least 90 days after the end of CELLCEPT administration
- 6. Patients treated with HIV or HCV protease inhibitors
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome will be a composite endpoint, named “treatment failure”, defined by the occurrence of any of the following events during the first 6 months (2nd objective) or during the first 18 months (1st objective) after transplantation: • Patient death, • Graft loss, • Biopsy-proven acute rejection, with a rejection activity index score ≥4 according to the Banff criteria
Secondary endpoints 6
- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4
- Comparison, between patients the four arms, at M6 andM18 post-transplantation, of: a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4
- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of: a. The proportion of non-adherent patients b. Mean PCS-QOL and MCS-QOL
- Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of the incidence of adverse events of interest
- Comparison, between patients on MMF BID and patients on MMF QD , at M18 post-transplantation, of: a. The proportion of non-adherent patients b. Mean PCS-QOL and MCS-QOL c. The incidence of adverse events of interest
- Comparison, between the four arms and at each post-transplantation period, of: a. Mean tacrolimus and MPA AUC0-24h, b. Mean tacrolimus C0/dose and AUC0-24h/dose, c. Mean MPA AUC0-24h/dose.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 27
Advagraf 1 mg prolonged-release hard capsules
PRD328675 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/003
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 1 mg prolonged-release hard capsules
PRD324618 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/006
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2153965 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 0.75 mg prolonged-release tablets
PRD1609516 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/003
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2153966 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 1 mg prolonged-release tablets
PRD1609562 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/005
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 1 mg prolonged-release tablets
PRD1609563 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/006
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 0.5 mg prolonged-release hard capsules
PRD324600 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/002
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CellCept 500 mg film-coated tablets
PRD2153968 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 2190 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 1 mg prolonged-release tablets
PRD1609561 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/004
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 4 mg prolonged-release tablets
PRD1609569 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/007
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 3 mg prolonged-release hard capsules
PRD328683 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/012
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8720514 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/007
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 0.75 mg prolonged-release tablets
PRD1609514 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/001
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 3 mg prolonged-release hard capsules
PRD328681 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/013
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 0.75 mg prolonged-release tablets
PRD1609515 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/002
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 3 mg prolonged-release hard capsules
PRD324632 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/011
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 4 mg prolonged-release tablets
PRD1609570 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/008
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 5 mg prolonged-release hard capsules
PRD324659 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/008
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 0.5 mg prolonged-release hard capsules
PRD330537 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/001
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 1 mg prolonged-release hard capsules
PRD328676 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/004
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 0.5 mg prolonged-release hard capsules
PRD324610 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/009
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 1 mg prolonged-release hard capsules
PRD324615 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/005
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CellCept 500 mg film-coated tablets
PRD2153969 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/004
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Envarsus 4 mg prolonged-release tablets
PRD1609571 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/14/935/009
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 5 mg prolonged-release hard capsules
PRD324633 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 54750 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/007
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 5 mg prolonged-release hard capsules
PRD324665 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg/Kg milligram(s)/kilogram
- Max total dose
- 54750 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/010
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Limoges
- Sponsor organisation
- Centre Hospitalier Universitaire De Limoges
- Address
- 2 Avenue Martin Luther King
- City
- Limoges
- Postcode
- 87000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Limoges
- Contact name
- Dr Caroline MONCHAUD
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Limoges
- Contact name
- Renaud MARTIN
Locations
1 EU/EEA country · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 200 | 18 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Dijon
hépato gastroentérologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Lille
maladies de l’appareil digestif, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Montpellier
Hépato-Gastroentérologie et Transplantation A, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopital Universitaire Pitie Salpetriere
Unité Médicale de Tansplantation Hépatique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Hopital Beaujon
Hépatologie, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Nice
Hépato-Gastroentérologie et oncologie digestive, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Rennes
maladies du foie et unité de Transplantation hépatique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Poitiers
Hépato-Gastroentérologie, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Paul Brousse
Centre Hépato-Biliaire, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Centre Hospitalier Universitaire De Limoges
Hépato Gastroentérologie, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Regional De Marseille
Chirurgie générale et transplantation hépatique, 264 Rue Saint Pierre, 13005, Marseille
Les Hopitaux Universitaires De Strasbourg
Chirurgie générale, hépatique, endocrinienne et transplantation, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Toulouse
Néphrologie et transplantation d'organes, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Chirurgie digestive, oncologique et endocrinienne, trasplantation hépatique, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
CHU Besancon
hépatologie, 3 Boulevard Alexandre Fleming, 25000, Besancon
Hopital De La Croix Rousse
Hépato Gastroentérologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Bordeaux
service Hépato-Gastroentérologie et oncologie digestive, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire Grenoble Alpes
Hépatogastroentérologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-04-15 | 2025-04-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocole_2023-506601-19 | 7 |
| Protocol (for publication) | D1_Protocole_2023-506601-19_TC | 7 |
| Protocol (for publication) | EASY_CARNETS PATIENTS_TRAITEMENTS | 2 |
| Protocol (for publication) | Questionnaire BAASIS_EASY | 1 |
| Protocol (for publication) | Questionnaire GSRS_EASY | 1 |
| Protocol (for publication) | Questionnaire MTSOSD-f-fr_EASY | 1 |
| Protocol (for publication) | Questionnaire MTSOSD-m-fr_EASY | 1 |
| Protocol (for publication) | Questionnaire sf-36v2 standard_EASY | 1 |
| Recruitment arrangements (for publication) | recruitment and informed consent procedure EASY | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_TC | 4 |
| Subject information and informed consent form (for publication) | NIFC_collection bio_EASY | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ADVAGRAF | 29 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CELLCEPT | 40 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ENVARSUS | 13 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsys_2023-506601-19 | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsys_2023-506601-19_TC | 7 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-07 | France | Acceptable 2024-05-28
|
2024-05-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-08 | France | Acceptable | 2024-08-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-11 | France | Acceptable 2024-11-06
|
2024-12-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-07 | France | Acceptable 2025-06-25
|
2025-06-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-03 | France | Acceptable 2025-10-05
|
2025-10-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-05 | France | Acceptable | 2026-04-09 |