A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Europe Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01614665
First received: June 6, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time.
This study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation Liver Transplantation Heart Transplantation |
Drug: Prograf® Drug: Advagraf |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated With an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Part A: Determine steady state systemic exposure (AUC0-24h) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A & B: Assessment of safety through the evaluation of adverse events, laboratory parameters and vital signs [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Part A: Determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A: Determine Tmax (time to attain Cmax) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A: Determine C24 (concentration prior to morning dose) [ Time Frame: Day 1, Day 7 and Day 28 ] [ Designated as safety issue: No ]
- Part A & B: Rejection episodes [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: No ]
- Part A & B: Subject and graft survival [ Time Frame: Up to 1 year (End of study) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Prograf® |
Drug: Prograf®
Oral
Other Names:
|
| Experimental: Advagraf® |
Drug: Advagraf
oral
Other Names:
|
Detailed Description:
Subjects undergoing primary heart, kidney or liver transplantation and meeting the Inclusion Criteria and complying with the Exclusion Criteria prior to initiation of tacrolimus therapy will be enrolled.
Subjects will be randomized to treatment with either Advagraf® or Prograf®. The randomization will be on a 1:1 basis stratified by organ and centre.
The study is divided in to two parts:
Part A: The initial pharmacokinetic part of the study.
Part B: A long term follow-up of one year. The main objective of Part A of the study is to collect PK data following administration of Advagraf® and Prograf® in de novo pediatric allograft recipients. Part B allows comparison of the safety and efficacy profiles of Advagraf® vs. Prograf® for longer term (52 weeks) post allograft transplantation.
Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subject is aged <16 years of age, undergoing primary liver, kidney or heart allograft transplantation
- The subject must be able to swallow intact Prograf® or Advagraf® capsules
- Subjects, treated since transplantation with Basiliximab or ATG/ Mycophenolate Mofetil (MMF)/steroids, whose gastric motility has resumed and whose renal function is adequate on Day 1
Exclusion Criteria:
- Subject is receiving a multi-organ transplant or has previously received an organ transplant (including re-transplantation)
- Subject with pulmonary vascular resistance ≥4 Wood units despite medication
- Subject with significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation. (Not applicable for renal transplanted subjects)
- Subject with significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels of ≥3 times the upper value of the normal range of the investigational site during the past 28 days. (Not applicable for liver transplanted subjects)
- Subject with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully. (Not applicable for transplanted subjects with a primary organ diagnosis of cancer)
- Subject requiring systemic immunosuppressive medication for any other indication than transplantation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614665
Contacts
| Contact: Medical Affairs Europe | + 44 1784 419400 | contact@nl.astellas.com |
Locations
| Austria | |
| Vienna General Hospital (AKH)/11 | Recruiting |
| Vienna, Austria | |
| Belgium | |
| K.U.Leuven/22 | Recruiting |
| Leuven, Belgium | |
| Czech Republic | |
| University Hospital Motol/61 | Recruiting |
| Prague, Czech Republic | |
| France | |
| Necker-Enfants Malades Hospital/32 | Not yet recruiting |
| Paris, Necker, France | |
| Italy | |
| Ospedali Riuniti di Bergamo/51 | Recruiting |
| Bergamo, Italy | |
| Ospedale Bambin Gesu/52 | Not yet recruiting |
| Rome, Italy | |
| Poland | |
| Children's Memorial Health Institute/71 | Recruiting |
| Warsaw, Poland | |
| Children's Memorial Health Institute/72 | Recruiting |
| Warsaw, Poland | |
| Silesian Center for Heart Disease/73 | Withdrawn |
| Zabrze, Poland | |
| United Kingdom | |
| Birmingham Children's Hospital/43 | Not yet recruiting |
| Birmingham, United Kingdom | |
| Great Ormond Street Hospital/41 | Not yet recruiting |
| London, United Kingdom | |
| Kings College Hospital/ 44 | Not yet recruiting |
| London, United Kingdom | |
| Royal Manchester Children's Hospital/42 | Recruiting |
| Manchester, United Kingdom | |
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
| Study Director: | Clinical Study Manager | Astellas Pharma Europe Ltd. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT01614665 History of Changes |
| Other Study ID Numbers: | PMR-EC-1207, 2011-000078-80 |
| Study First Received: | June 6, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Heart Kidney Liver Transplant Immunosuppression |
Advagraf Prograf Tacrolimus Pediatric Pharmacokinetic |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013