A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation (OPTION)

Astellas

Status and phase

Completed

Phase 4

Conditions

Liver Transplantation

Kidney Transplantation

Heart Transplantation

Treatments

Drug: Tacrolimus granules

Study type

Interventional

Funder types

Industry

Identifiers

NCT01371331

F506-CL-0403

2009-012258-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

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