Intestine TransplantationPhase 2NCT01294020
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
A Phase 2 study testing Tacrolimus and Tacrolimus prolonged release in people with Intestine Transplantation and Kidney Transplantation, run by Astellas Pharma Europe Ltd. at 16 sites in 7 countries.
Trial summary
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation
- What is being tested?
- Tacrolimus and Tacrolimus prolonged release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 25 May 2011to 3 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must be able to swallow intact study medication capsules
- 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
- Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
- Negative pregnancy test prior to enrolment (females)
- Must agree to practice effective birth control during the study
- Stable whole blood trough levels of tacrolimus in the range of 3.5 - 15ng/mL (+/-0.5ng/mL) and clinically stable in the opinion of the Investigator
Who cannot join
- Previously received a multiple organ transplant
- Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months
- Currently receiving Rapamycin, Certican or MPA (Myfortic®)
- Chronic dysfunction of the allograft, in the opinion of the Investigator
- Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study
- The subject is pregnant or breast feeding
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
France5 sites
Site FR34
Bron, 69677
Site FR35
Bron, 69677
Site FR31
Paris, 75743
Site FR32
Paris, 75743
Site FR33
Paris, 75908
United Kingdom3 sites
Site GB62
Birmingham, B4 6NH
Site GB64
London, WC1 3JH
Site GB61
Manchester, M27 4HA
About this study
Official title: A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
Read the detailed description
Part A: 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 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 over a 24-hour period and will be completed on Day 15.
Part B: One year follow-up period to evaluate safety and efficacy of tacrolimus when administered as an Advagraf®-based immunosuppressive regimen.
Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have completed 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.
Part C applies to patients in the following countries: United Kingdom, Czech Republic, Germany, Italy, and Poland only.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation, Heart Transplantation
- Being tested
- Tacrolimus, Tacrolimus prolonged release
- Keywords
- Transplant, Liver, Tacrolimus, Kidney, Heart, Lung, Immunosuppression, Advagraf, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf, FK506
Oral capsule
Tacrolimus prolonged releaseDrug
Also called FK506E, MR4, Advagraf, tacrolimus modified release
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus Prolonged Release | Experimental | Participants converted from their routine tacrolimus based immunosuppressive regimen to tacrolimus as a study medication twice daily on day 1 and continued to receive treatment up to day 7. On day 8, participants switched to tacrolimus prolonged release once daily and received treatment up to day 14 in Part A of the study. In Part B, participants continued to receive tacrolimus prolonged release once daily from day 15 for a one-year follow-up period. In Part C, participants continued to receive tacrolimus prolonged release once daily when commercial tacrolimus prolonged release was not available. Part C continued until commercial tacrolimus prolonged release became available to participants (≥ 18 years of age) or the participants discontinued tacrolimus prolonged release, whichever occurred first. Receives: Drug: Tacrolimus; Drug: Tacrolimus prolonged release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve from Time 0 to Time 24 Hours (AUC0-24h) for Tacrolimus and Tacrolimus Prolonged Release
Measured: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Number of Participants with Adverse Events (Part C)
Measured: From first dose of tacrolimus prolonged release in Part C (12 months) up to 7 days after last dose (approximately 10 years)
Secondary outcomes (11)
Maximum Concentration (Cmax) of Tacrolimus and Tacrolimus Prolonged Release
Measured: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Time to Attain Maximum Concentration (tmax) of Tacrolimus and Tacrolimus Prolonged Release
Measured: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Trough Concentration (C24) for Tacrolimus and Tacrolimus Prolonged Release
Measured: Days 7 and 14, 24 hours after dosing
Number of Participants with Acute Rejections
Rejection episodes/acute rejections are indicated by clinical and/or laboratory signs, and are classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment was used.
Measured: Up to Week 54
Number of Participants with Biopsy Proven Acute Rejections (BPARs)
BPAR episodes are defined as acute rejection episodes confirmed by biopsy, and are classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment used.
Measured: Up to Week 54
Severity of Biopsy Proven Acute Rejection Episodes
The severity of BPARs is categorized with specific criteria by organ: For kidney transplant participants, according to Banff '97 Diagnostic categories for renal allograft biopsies - Banff '07 update (Acute antibody-mediated rejection I, II, and III, Acute T cell mediated rejection IA, IB, IIA, IIB and III); for liver transplant participants, according to 1997 Banff Schema for grading of Liver Allograft Rejection (mild, moderate, severe or indeterminate/borderline); for heart, according to Standardized Nomenclature of the International Society of Heart and Lung Transplantation (mild, moderate, severe).
Measured: Up to Week 54
Patient survival
Patient survival is defined as the time from first dose of tacrolimus as study drug to the date of death from any cause
Measured: Up to Week 54
Graft survival
Graft survival is defined as the time from the first dose of tacrolimus as study drug to graft loss. Graft loss is defined as retransplantation, nephrectomy (in case of kidney transplantation), death or dialysis (in case of kidney transplantation) ongoing at end of study or at discontinuation, unless superseded by follow-up information.
Measured: Up to Week 54
Efficacy Failure
Efficacy failure is defined as the composite of the following: death, graft loss, BPAR and unknown outcome.
Measured: Up to Week 54
Number of Participants with Adverse Events (Part A)
Safety as assessed by adverse events (AEs), which includes abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) is an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, is life-threatening, required or prolonged hospitalization or is considered medically important.
Measured: From first dose of tacrolimus up to 7 days after last dose of tacrolimus prolonged release in Part A (up to 21 days)
Number of Participants with Adverse Events (Part B)
Safety as assessed by adverse events (AEs), which includes abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) is an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, is life-threatening, required or prolonged hospitalization or is considered medically important.
Measured: From first dose of tacrolimus prolonged release in Part A up to 7 days after last dose of tacrolimus prolonged release in Part B (up to 55 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study start25 May 2011
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestine TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294020
- Sponsor's protocol ID
- PMR-EC-1206
- Other IDs
- 2010-020925-42, 2024-513546-11-00
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2011
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT01294020
- Acronym / sponsor ID
- PMR-EC-1206
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation, Heart Transplantation
- Keywords
- Transplant, Liver, Tacrolimus, Kidney, Heart, Lung, Immunosuppression, Advagraf
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2011 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
Detailed description
Part A: 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 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 over a 24-hour period and will be completed on Day 15.
Part B: One year follow-up period to evaluate safety and efficacy of tacrolimus when administered as an Advagraf®-based immunosuppressive regimen.
Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have completed 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.
Part C applies to patients in the following countries: United Kingdom, Czech Republic, Germany, Italy, and Poland only.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Prolonged Release | Experimental | Drug: Tacrolimus, Drug: Tacrolimus prolonged releaseParticipants converted from their routine tacrolimus based immunosuppressive regimen to tacrolimus as a study medication twice daily on day 1 and continued to receive treatment up to day 7. On day 8, participants switched to tacrolimus prolonged release once daily and received treatment up to day 14 in Part A of the study. In Part B, participants continued to receive tacrolimus prolonged release once daily from day 15 for a one-year follow-up period. In Part C, participants continued to receive tacrolimus prolonged release once daily when commercial tacrolimus prolonged release was not available. Part C continued until commercial tacrolimus prolonged release became available to participants (≥ 18 years of age) or the participants discontinued tacrolimus prolonged release, whichever occurred first. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Must be able to swallow intact study medication capsules
- 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
- Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
- Negative pregnancy test prior to enrolment (females)
Key exclusion criteria (6 listed)
- Previously received a multiple organ transplant
- Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months
- Currently receiving Rapamycin, Certican or MPA (Myfortic®)
- Chronic dysfunction of the allograft, in the opinion of the Investigator
- Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: Prograf, FK506Oral capsule | Drug | Tacrolimus Prolonged Release |
| Tacrolimus prolonged releaseAlso: FK506E, MR4, Advagraf, tacrolimus modified releaseOral capsule | Drug | Tacrolimus Prolonged Release |
Primary outcome
Area Under the Plasma Concentration-time Curve from Time 0 to Time 24 Hours (AUC0-24h) for Tacrolimus and Tacrolimus Prolonged Release
Time frame: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Number of Participants with Adverse Events (Part C)
Time frame: From first dose of tacrolimus prolonged release in Part C (12 months) up to 7 days after last dose (approximately 10 years)
11 secondary outcomes
Maximum Concentration (Cmax) of Tacrolimus and Tacrolimus Prolonged Release
Time frame: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Time to Attain Maximum Concentration (tmax) of Tacrolimus and Tacrolimus Prolonged Release
Time frame: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Trough Concentration (C24) for Tacrolimus and Tacrolimus Prolonged Release
Time frame: Days 7 and 14, 24 hours after dosing
Number of Participants with Acute Rejections
Time frame: Up to Week 54
Number of Participants with Biopsy Proven Acute Rejections (BPARs)
Time frame: Up to Week 54
Severity of Biopsy Proven Acute Rejection Episodes
Time frame: Up to Week 54
Patient survival
Time frame: Up to Week 54
Graft survival
Time frame: Up to Week 54
Efficacy Failure
Time frame: Up to Week 54
Number of Participants with Adverse Events (Part A)
Time frame: From first dose of tacrolimus up to 7 days after last dose of tacrolimus prolonged release in Part A (up to 21 days)
Number of Participants with Adverse Events (Part B)
Time frame: From first dose of tacrolimus prolonged release in Part A up to 7 days after last dose of tacrolimus prolonged release in Part B (up to 55 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study chair
Astellas Pharma Europe Ltd.
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus and Tacrolimus prolonged release in people with Intestine Transplantation and Kidney Transplantation, run by Astellas Pharma Europe Ltd. at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, United Kingdom, Belgium, Italy, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-time Curve from Time 0 to Time 24 Hours (AUC0-24h) for Tacrolimus and Tacrolimus Prolonged Release (time frame: Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.