A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation (OPTION)
This study is currently recruiting participants.
Verified April 2013 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01371331
First received: June 9, 2011
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Transplantation Kidney Transplantation Heart Transplantation |
Drug: Tacrolimus granules |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Determine AUCtau (area under the plasma concentration-time curve for a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
- Determine Cmax (maximum concentration) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
- Determine tmax (time to attain Cmax) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
- Determine Ctrough (plasma concentration at the end of a dosing interval) [ Time Frame: on Day 1 and Day 7 (+/- 7 days) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rejection episodes [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Patient survival [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Graft survival [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tacrolimus granules |
Drug: Tacrolimus granules
oral
Other Name: Modigraf
|
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.
Eligibility| Ages Eligible for Study: | up to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371331
Contacts
| Contact: Medical Affairs Europe | + 44 1784 419400 | contact@nl.astellas.com |
Locations
| Belgium | |
| Site 40 | Active, not recruiting |
| Brussels, Belgium, 1200 | |
| Germany | |
| Site 31 | Active, not recruiting |
| Hannover, Germany, 30625 | |
| Site 30 | Recruiting |
| Heidelberg, Germany, 69120 | |
| Poland | |
| Site 50 | Recruiting |
| Warsaw, Poland, 04-730 | |
| Spain | |
| Site 20 | Active, not recruiting |
| Madrid, Spain, 28046 | |
| Site 21 | Recruiting |
| Madrid, Spain, 28046 | |
| Site 22 | Recruiting |
| Madrid, Spain, 28007 | |
| United Kingdom | |
| Site 10 | Terminated |
| Birmingham, United Kingdom, B4 6NH | |
| Site 11 | Withdrawn |
| London, United Kingdom, WC1N3JH | |
| Site 13 | Recruiting |
| Manchester, United Kingdom, M13 9WL | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Senior Study Manager | Astellas Pharma Europe Ltd. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01371331 History of Changes |
| Other Study ID Numbers: | F506-CL-0403, 2009-012258-19 |
| Study First Received: | June 9, 2011 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Germany: Ministry of Health Spain: Ministry of Health Poland: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Kidney Transplantation Liver Transplantation Heart Transplantation Pharmacokinetics |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013