Prophylaxis of transplant rejection in adult kidney allograft recipients. MedDRA version: 16.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is eligible for the study if all of the following apply: 1. Aged = 18 years and undergoing primary kidney allograft transplantation. 2. Receiving a kidney transplant from a deceased donor with compatible ABO blood type. 3. Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment. 4. Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after end of study participation. 5. Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent has been obtained). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Subject will be excluded from participation if any of the following apply: 1. Receiving a multi-organ transplant or has previously received an organ transplant. 2. Significant uncontrolled diabetes or liver disease, defined as having continuously elevated SGPT/ ALT and/ or SGOT/ AST and/ or total bilirubin levels = 2 times the upper value of the normal range of the investigational site. 3. Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s). 4. Requiring systemic immunosuppressive medication for any indication other than transplantation. 5. Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. 6. Pregnant woman or breast-feeding mother. 7. Subject or donor known to be HIV or HCV or HBV positive. 8. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids or MMF. 9. Previous exposure to Tacrolimus or requirement for multiple pre-operative doses of Advagraf®. 10. Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment. 11. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator. 12. Unlikely to comply with the visits scheduled in the protocol. 13. Subject is taking or requiring to be treated with medication or substances known to interfere with tacrolimus metabolism 14. Any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 3 after transplantation.;Main Objective: The primary objective of the study is to assess if Advagraf® pharmacokinetic parameters measured prior to transplantation can predict the dose required after transplantation to achieve target trough levels of 10 ng/mL in individual patients. ;Secondary Objective: The secondary objective of the study is to evaluate the influence of pharmacogenetics on early post-transplant exposure to tacrolimus. ;Primary end point(s): • The primary variable is dose of tacrolimus required to achieve a trough level of 10 ng/mL on Day 3 after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Dose-normalised trough concentration of tacrolimus on Day 7 and Day 14 after transplantation • Tacrolimus trough concentrations on Day 7 and Day 14 after transplantation • Tacrolimus concentrations 1, 2 and 3 hours (C1, C2, C3) after pre-transplant test dose • AUC0-3 following the test dose • Cmax, tmax following the test dose • Genetic polymorphisms in CYP3A4/5 and ABCB1 genes • Delayed graft function • Biopsy Confirmed Acute Rejection (BCAR) • Incidence of Adverse Events (AEs) • Laboratory parameters • Vital signs ;Timepoint(s) of evaluation of this end point: Day -1 (pre-operative): 1, 2 and 3 hours after pre-transplant test dose Day 1, Day 3, Day 7 and Day 14 (post-operative) | — |
Countries
Italy
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed