Prophylaxis of heart, liver and kidney transplant rejection in paediatrics MedDRA version: 14.0 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.0 Level: LLT Classification code 10050432 Term: Prophylaxis against heart transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.0 Level: LLT Classification code 10050436 Term:
Conditions
Interventions
Trade Name: Advagraf
Product Name: -
Product Code: -
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Co
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The subject is aged =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the systemic exposure (AUC0-24h) of tacrolimus for Advagraf® versus Prograf® after the first dose and following repeated administration in pediatric subjects undergoing de novo allograft transplantation of kidney, liver or heart.;Secondary Objective: To observe the long-term safety and efficacy profile of tacrolimus for Advagraf® with that of Prograf® in pediatric subjects undergoing de novo allograft transplantation of kidney, liver or heart.;Primary end point(s): Primary Pharmacokinetic Variables • The systemic exposure (AUC0-24h at each of Day 1, Day 7 and Day 28) of tacrolimus after first dose and under steady state conditions. Primary Safety Variables • AEs • Laboratory parameters • Vital signs;Timepoint(s) of evaluation of this end point: AUC0-24h at each of Day 1, Day 7 and Day 28. Long term safety at 2, 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Pharmacokinetic Variables The following PK parameters for tacrolimus will be determined for each profile • Cmax • tmax • C24 Efficacy Variables • Rejection episodes • Subject and graft survival ;Timepoint(s) of evaluation of this end point: PK variables at Day 1, Day 7 and Day 28 Long term efficacy variables at 2, 3, 6 and 12 months. | — |
Countries
Austria, Czech Republic, France, Italy, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe
Outcome results
None listed