Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
13
Countries
1
Sites
1
Prophylaxis of primary liver, kidney, heart, lung, and intestinal organ transplant rejection
To compare the steady state AUC0-24h of tacrolimus for Advagraf® with that of Prograf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf®.
Key facts
- Sponsor
- Astellas Pharma Europe Limited
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 10 Mar 2014 → 4 Nov 2025
- Decision date (initial)
- 2024-06-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Astellas Pharma Europe Limited
External identifiers
- EU CT number
- 2024-513546-11-00
- EudraCT number
- 2010-020925-42
- ClinicalTrials.gov
- NCT01294020
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Therapy, Prophylaxis, Safety
To compare the steady state AUC0-24h of tacrolimus for Advagraf® with that of Prograf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf®.
Secondary objectives 1
- To observe the long-term safety and efficacy profile of tacrolimus for Advagraf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf® and to evaluate the relationship between AUC0-24h and C24 for Advagraf® and for Prograf® at each PK profile.
Conditions and MedDRA coding
Prophylaxis of primary liver, kidney, heart, lung, and intestinal organ transplant rejection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10050432 | Prophylaxis against heart transplant rejection | 10042613 |
| 21.1 | LLT | 10050436 | Prophylaxis against renal transplant rejection | 10042613 |
| 21.1 | LLT | 10052062 | Prophylaxis against intestinal transplant rejection | 10042613 |
| 21.1 | LLT | 10050433 | Prophylaxis against lung transplant rejection | 10042613 |
| 21.1 | LLT | 10050434 | Prophylaxis against liver transplant rejection | 10042613 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part A - Pharmacokinetics (completed prior to transition) Subjects will enter a 30 day screening period (Day -30 to Day -1) during which time they will be maintained on their routine twice daily Prograf® based immunosuppressive regimen as determined by the Investigator and supplied by the local hospital pharmacy.
On Day 1 subjects will be converted from their routine Prograf® based immunosuppressive regimen to a Prograf® based immunosuppressive regimen supplied by the Sponsor as study medication and continue treatment until Day 7. The daily dose of the study medication must be the same [1:1 (mg:mg)] as the Prograf® dose received during the 30 day screening period.
On Day 7 the first 24 hour PK profile will be started. Samples will be taken as specified in the protocol over a 24 hour period and will be completed on Day 8.
On Day 8 subjects will be switched to once daily Advagraf® on a 1:1 (mg:mg) total daily dose basis and continue treatment until Day 14.
On Day 14 the second 24 hour PK profile will be started. Samples will be taken as specified in the protocol over a 24 hour period and will be completed on Day 15.
|
Not Applicable | None | ||
| 2 | Part B - Long-Term Follow-Up (completed prior to transition) A long-term follow-up period to evaluate the safety and efficacy of tacrolimus when administered as an Advagraf® based immunosuppressive regimen will follow completion of the second PK profile on Day 15.
Following Part A of the study, all subjects who have been administered at least one dose of Advagraf® study medication will continue in the long-term follow-up part of this study (Part B) in which they can continue to be administered Advagraf®, if in the opinion of the Investigator they are likely to benefit from this. Subjects will participate in Part B of the study for 12 months following completion of Part A (Visit 4).
Part B follow up visits will take place 6, 10, 14, 28, 42 and 54 weeks after Day 1.
Part B of the study is intended to collect safety and efficacy data of Advagraf® over 12 months post-conversion from Prograf®
|
Not Applicable | None | ||
| 3 | Part C - Continuation of Long-Term Follow-Up Patients who have complete Part B and to whom continued treatment with Advagraf is not currently available, will be offered participation in a continuation of long-term follow-up Part C. Part C will continue until Advagraf becomes available to these patients or these patients
discontinuation, whichever is the earliest.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- The subject is at least 5 years and not older than 16 years of age, inclusive.
- The subject must be able to swallow intact study medication capsules.
- The subject received a single solid organ transplant at least 6 months prior to entry into the study.
- The subject’s parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable.
- The subject has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
- Female subjects of child bearing potential must provide a negative urine or serum pregnancy test prior to enrolment in the study
- Male and female subjects that are sexually active must agree to practice effective birth control during the study. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner).
- Additional Inclusion Criterion on Day 1: Subject has stable whole blood trough levels of tacrolimus in the range of 3.5-15 ng/mL measured on at least 2 separate occasions taken at least 6 days apart within 30 days prior to Day 1 and is clinically stable in the opinion of the Investigator.
Exclusion criteria 12
- The subject has previously received a multiple organ transplant.
- The subject has experienced any rejection episode within 3 months prior to enrolment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months.
- The subject is currently receiving Rapamycin, Certican or MPA (Myfortic®).
- The subject has a chronic dysfunction of the allograft, in the opinion of the Investigator.
- The subject had major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study.
- The subject has any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator.
- The subject is known to be positive for either HBV or HCV or HIV.
- The subjects is required to be treated with medication or substances known to interfere with tacrolimus metabolism as listed in Appendix 1, or having taken such medication within 28 days prior to inclusion.
- The subject is pregnant or breast feeding.
- The subject has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator.
- The subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational/non-registered drug in the past 28 days.
- The subject is unlikely to comply with the visits scheduled in the protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The steady state systemic exposure (AUC0-24h) of tacrolimus when administered as Advagraf® or Prograf® in stable pediatric allograft recipients.
Secondary endpoints 3
- Secondary pharmacokinetic variables: Cmax; tmax; C24
- Safety: Incidence of adverse events; Laboratory parameters; Vital signs
- Efficacy: Rejection episodes; Subject and graft survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 26
Advagraf 1 mg prolonged-release hard capsules
PRD328678 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/019
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- 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
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 0.5 mg prolonged-release hard capsules
PRD324616 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/016
- 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
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 5 mg prolonged-release hard capsules
PRD324665 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 0.5 mg prolonged-release hard capsules
PRD330537 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
PRD324620 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/018
- 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
PRD328675 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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 3 mg prolonged-release hard capsules
PRD328682 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/021
- 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
PRD324633 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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 0.5 mg prolonged-release hard capsules
PRD324610 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
PRD324625 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/017
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 3 mg prolonged-release hard capsules
PRD328684 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/023
- 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
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 1 mg prolonged-release hard capsules
PRD324630 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/020
- 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
PRD324600 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 3 mg prolonged-release hard capsules
PRD328692 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/022
- 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
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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 5 mg prolonged-release hard capsules
PRD324660 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/024
- 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
PRD324666 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/026
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- 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
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 3 mg prolonged-release hard capsules
PRD328683 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
Advagraf 5 mg prolonged-release hard capsules
PRD324659 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 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
PRD324613 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/015
- 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
PRD324612 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/014
- 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
PRD324668 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.30 mg/kg milligram(s)/kilogram
- Max total dose
- 1423.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 156 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/025
- 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
Astellas Pharma Europe Limited
- Sponsor organisation
- Astellas Pharma Europe Limited
- Address
- 300 Dashwood Lang Road, Bourne Business Park Bourne Business Park
- City
- Addlestone
- Postcode
- KT15 2NX
- Country
- United Kingdom
Scientific contact point
- Organisation
- Astellas Pharma Europe Limited
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Public contact point
- Organisation
- Astellas Pharma Europe Limited
- Contact name
- Head of Clinical Trial Unit Regulatory Affairs
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Haupt Pharma Wuelfing GmbH ORG-100012207
|
Gronau Leine, Germany | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 13, Data management, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 13 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Czechia | 2014-03-10 | 2025-11-03 | 2014-03-21 | 2016-10-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of Results SUM-134567
|
2026-05-19T15:55:05 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary | 2026-05-19T15:55:14 | Submitted | Laypersons Summary of Results |
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary of Results | N/A |
| Protocol (for publication) | D1 01_PMR-EC-1206_Protocol_2024-513546-11-00_en_fp | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 02_SmPC Advagraf | n/a |
| Summary of results (for publication) | Summary of Result | 1.0 |
| Synopsis of the protocol (for publication) | D1 02_PMR-EC-1206_ProtocolSynopsis_2024-513546-11-00_CZ_cz | 8.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-28 | Czechia | Acceptable with conditions 2024-06-26
|
2024-06-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-12 | Czechia | Acceptable with conditions 2024-06-26
|
2025-06-12 |