A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation (OPTION)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371331
: June 10, 2011
Last Update Posted
: March 9, 2017
Astellas Pharma Europe Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
up to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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