Kidney TransplantationPhase 4OPTIONNCT01371331
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
A Phase 4 study testing Tacrolimus granules in people with Kidney Transplantation and Heart Transplantation, run by Astellas Pharma Europe Ltd. at 10 sites in 6 countries.
Trial summary
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- What is being tested?
- Tacrolimus granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 9 Jun 2011to 3 Feb 2015
- Phase
- Phase 4
- 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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart
Who cannot join
- The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation)
- Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA) score >50% in the previous 6 months (only applicable for renal transplant recipients)
- Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients)
- Subject receives an AB0 incompatible donor organ
- Subject has significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients)
- Subject has significant liver disease, defined as having elevated Alanine Aminotransferase (ALT) and/or Asparate Aminotransferase (AST) and/or Total Bilirubin levels 3 times the upper value of the normal range during the 28 days prior to transplantation (not applicable for liver transplant recipients)
Show all 15Show fewer
- Subject with pulmonary vascular resistance greater than 4 Wood units which is unresponsive to treatment
- Subjects with malignancies or a history of malignancy within the last 5 years
- Subject has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer
- Subject requires systemic immunosuppressive medication for any indication other than transplantation
- Recipient or donor known to be HIV, HCV or HBV positive
- Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus
- Subject is currently participating in another clinical trial and/or has been taking an investigational drug in the 3 months prior to transplantation
- Subject is unlikely to comply with the visits scheduled in the protocol
- Subjects taking or requiring to be treated with medication or substances prohibited by this protocol
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United Kingdom2 sites
Site 10
Birmingham, B4 6NH
Site 13
Manchester, M13 9WL
About this study
Official title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
Read the detailed description
The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.
- Being tested
- Tacrolimus granules
- Keywords
- Kidney Transplantation, Pharmacokinetics, Heart Transplantation, Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus granulesDrug
Also called Modigraf
oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus granules | Experimental | oral Receives: Drug: Tacrolimus granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
Measured: on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)
Measured: on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)
Measured: on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)
Measured: on Day 1 and Day 7 (+/- 7 days)
Secondary outcomes (4)
Rejection episodes
Measured: 14 days
Patient survival
Measured: 14 days
Graft survival
Measured: 14 days
Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study start9 Jun 2011
- Primary completion3 Feb 2015
- Study completion3 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Study Manager, Study chair, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371331
- Sponsor's protocol ID
- F506-CL-0403
- Other IDs
- 2009-012258-19, 2009
- Acronym
- OPTION
- Status last verified
- Oct 2024
- First submitted
- 9 Jun 2011
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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/.
Publications
Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.
PubMed 30665258
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
- ClinicalTrials.gov ID
- NCT01371331
- Acronym / sponsor ID
- OPTION / F506-CL-0403
- Keywords
- Kidney Transplantation, Pharmacokinetics, Heart Transplantation, Liver Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2011 (actual)
- Primary completion
- 3 Feb 2015 (actual)
- Study completion
- 3 Feb 2015 (actual)
- First posted
- 10 Jun 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.
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
Detailed description
The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus granules | Experimental | Drug: Tacrolimus granulesoral |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart
Key exclusion criteria (15 listed)
- The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation)
- Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA) score >50% in the previous 6 months (only applicable for renal transplant recipients)
- Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients)
- Subject receives an AB0 incompatible donor organ
- Subject has significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients)
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 |
|---|---|---|
| Tacrolimus granulesAlso: Modigraforal | Drug | Tacrolimus granules |
Primary outcome
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)
Time frame: on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)
Time frame: on Day 1 and Day 7 (+/- 7 days)
4 secondary outcomes
Rejection episodes
Time frame: 14 days
Patient survival
Time frame: 14 days
Graft survival
Time frame: 14 days
Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs
Time frame: 14 days
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 1 Nov 2024.
- Derived from this study: PubMed 30665258Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.
- 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.
Senior Study Manager study chair
Astellas Pharma Europe Ltd.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus granules in people with Kidney Transplantation and Heart Transplantation, run by Astellas Pharma Europe Ltd. at 10 sites in 6 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 1 inclusion and 15 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Germany, United Kingdom, Belgium, France and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval) (time frame: on Day 1 and Day 7 (+/- 7 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371331, which also lists 1 linked publication.
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 1 Nov 2024.