Immunosuppression in adult de-novo kidney transplant MedDRA version: 18.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Envarsus 0.75 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: tacrolimus
CAS Number: 109581-93-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject's written informed consent obtained prior to any study-related procedure; 2. Adult caucasian male and female patients at least 18 years of age; 3. Recipients of a kidney transplant from a deceased donor or a living donor including patients undergoing a second kidney transplant. 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. For female subjects, pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the reliable methods of contraception; 2. Recipient of any transplanted organ other than a kidney; 3. Recipients of a bone marrow or stem cell transplant; 4. Recipients of a kidney from a cardiac death donor; 5. Recipients of a kidney from an ABO incompatible donor; 6. Recipients with TGI (Taux de Greffons Incompatibles histories, i.e. rate of graft incompatible among donors over the past 5 years) > 85% and/or having pre-transplant donor-specific anti-HLA antibodies (DSA); 7. Recipients of a kidney with an anticipated cold ischemia time = 24 hours; 8. Recipients positive for Hepatitis C virus (HCV-RNA positive) and/or Hepatitis B Virus (HBV-DNA or HBsAg positive)*; 9. Recipients positive for Human Immunodeficiency Virus (HIV-Ab positive)*; 10. Patients with a current malignancy or a history of malignancy ; 11. Patients with an uncontrolled concomitant infection;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare tacrolimus pharmacokinetics early after transplantation following administration of Envarsus® tablets or Advagraf® capsules in adult de-novo kidney transplant recipients;Secondary Objective: - To compare the safety of Envarsus® tablets and Advagraf® capsules ;Primary end point(s): Pharmacokinetic and dose adjustment variables;Timepoint(s) of evaluation of this end point: For pharmacokinetic variables, fixed time points over a 24h period on day 1, 3, 7 and 14 For dose adjustement, single blood sample preceding morning dose on day 2, 3, 4, 5, 6, 7, 8, 14, 15, 21 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety variables including AEs, ADRs and incidence of delayed graft function;Timepoint(s) of evaluation of this end point: Throughout study duration | — |
Countries
France
Contacts
Public ContactClinical Project Manager
Chiesi Farmaceutici S.p.A.
Outcome results
None listed