Prophylaxis of primary heart, lung, pancreas, (including simultaneous pancreas kidney [SPK]) organ transplant rejection. MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050432 Term: Prophylaxis against heart transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050435 Term: Prophylaxis against pancreas transplant rejection MedDRA version: 12.1 Level: LLT
Conditions
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18 and 65 years, undergoing primary allograft transplantation of heart, lung, pancreas or SPK. 2. Subjects must receive first oral dose of tacrolimus 1 day (lung, pancreas or SPK recipients) or 3 days (heart recipients) after transplantation (skin closure). 3. Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment. 4. Male and female subjects that are sexually active must agree to practice effective birth control during the study 5. Subjects capable of understanding the purpose and risks of the study, who have been fully informed and have given written informed consent to participate in the study. Additional Inclusion Criteria on Day 1: 6. Subjects, treated since transplantation with ATG/MMF/steroids, whose gastric motility has resumed and whose renal function is adequate (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects receiving a multi-organ transplant (with the exception of SPK) or having previously received an organ transplant (including re-transplantation). 2. Subjects with pulmonary vascular resistance =4 Wood units despite medication. 3. Subjects requiring an emergency ventricular assist device within one week prior to transplantation. 4. Subjects with significant renal impairment, defined as having serum creatinine =230 µmol/l (=2.6 mg/dl) pre-transplantation (except for pancreas/SPK transplant recipients) 5. Subjects 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. 6. Subjects 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. 7. Subjects with significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or active peptic ulcer. 8. Subjects requiring systemic immunosuppressive medication for any other indication than transplantation. 9. Subjects with a diagnosis of cystic fibrosis. 10. Subjects or donors known to be HIV or HCV or HBV positive. 11. Subjects allergic or intolerant to steroids, macrolide antibiotics, MMF or tacrolimus. 12. Subjects pregnant or breast-feeding. 13. Subjects unlikely to comply with the visits scheduled in the protocol. 14. Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator. 15. Subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational/non-registered drug in the past 28 days. 16. Subjects taking or requiring to be treated with medication or substances known to interfere with tacrolimus metabolism and listed in section below ‘Prohibited Concomitant Medication’ or having taken such medication within 28 days prior to inclusion (or within 5 days prior to inclusion for prohibited proton pump inhibitors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the AUC0-24h of tacrolimus for Advagraf® versus Prograf® after the first dose and following repeated administration in subjects undergoing primary heart, lung, pancreas (including simultaneous pancreas kidney [SPK]) transplantation.;Secondary Objective: The secondary objective of the study is to compare the long term safety and efficacy profile of tacrolimus for Advagraf® with that of Prograf® in subjects undergoing primary heart, lung, pancreas (including SPK) transplantation.;Primary end point(s): Part A The primary PK variable is systemic exposure (AUC0-24h) of tacrolimus after first dose and under steady state conditions. Part B The safety of tacrolimus will be described from the following parameters: • Incidence of AEs • Laboratory parameters • Vital signs | — |
Countries
Austria, Italy, United Kingdom
Outcome results
None listed