REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS MedDRA version: 18.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Envarsus
Product Name: Envarsus
Product Code: LCP-TACRO
Pharmaceutical Form: Tablet
INN or Proposed INN: LCP-TACRO
Other descriptive name: TACROLIMUS MONOHYDRATE
Concentration unit: mg mil
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (? 18 years). ? Receivers cadaveric renal graft or living donor with more than 6 months post-transplant evolution. ? Patients receiving Prograf stable and stable TAC trough concentrations between 5-10ng / ml non-interrupted oral dose for at least 10 days (steady state conditions). ? receiving concomitant immunosuppressive medication allowed: sodium or mycophenolate mofetil and corticosteroids. ? Subjects must be willing to give their written informed consent to testing and be able to do consent. If a subject can not give written informed consent independently, you can do your legal representative instead. ? Women of childbearing age must undergo a pregnancy test at the time of inclusion and accept the use of a medically acceptable method of contraception during the selection and receive medication as specified in the protocol. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: ? Patients on dialysis or treatment of rejection after transplantation. ? Patients treated with substances with potential interaction with TAC, particularly potent inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin or rifabutin). ? Patients participating in another clinical trial or treated with any investigational drug within 30 days prior to inclusion. ? Patients with liver disease. ? The patient or donor with the current diagnosis or history of malignancy within the past 5 years except carcinoma nonmetastatic basal or squamous cell skin treated successfully. ? pregnant or breast-feeding women and all women of childbearing age unless they use reliable contraception. A pregnancy test will be performed at screening and at the end of the study. ? Receiver of any other organ transplanted kidney. ? The recipients of bone marrow or stem cell transplant. ? Recipients of a kidney from a donor ABO incompatible. ? Patients with donor specific anti-HLA antibodies. ? Recipients of a kidney with anticipated cold ischemia time of ? 24 hours. ? Patients with concomitant uncontrolled infection, systemic infection in treatment, or any other unstable medical condition that could interfere with the study objectives. ? Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that can affect the absorption of TAC. ? Patients with white blood cell count ? 2.8 x 109 / L unless the absolute neutrophil count (ANC) is ? 1.0 x 109 / L ? Patients with platelet count ? 50 x 109 / L ? Patients with levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding> 3 times the upper limit of normal during the 30 days prior to the transplant procedure. ? Patients with known hypersensitivity to TAC or any of the excipients in the formulation Envarsus®. ? unable to swallow study medication patients. ? Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the investigator's opinion, may invalidate the communication with the investigator. ? Patients who require a high intake of potassium or potassium-sparing diuretics. ? Patients treated with substances with known nephrotoxic or neurotoxic effects. ? positive for hepatitis C virus (HCV-RNA positive) and / or hepatitis B virus (HBV DNA or HBsAg positive) receivers. ? positive for human immunodeficiency virus (HIV-Ab positive) receivers. ? unable to understand the effects and risks of the study, who can not give informed consent in writing or unwilling to comply with the study protocol patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the area under the curve (AUC) of CN activity after administration of a sustained release formulation (LCP- Tacro, Envarsus®) compared to an immediate release formulation (Prograf®) of TAC in renal transplant patients.;Secondary Objective: 1. pharmacokinetic study AUC 0-24 h of each TAC formulation 12h (Prograf®) and the new formulation of TAC every 24h (LCP- Tacro, Envarsus®). 2. Study PK / PD: To establish the relationship PK TAC (drug exposure) and PD (activity CN) of both formulations. Set TAC trough concentrations for optimal inhibition of CN. 3. Analysis of drug exposure according to CYP3A (CYP3A4 and CYP3A5 * 22 * 3) and ABCB1 (C3435T) polymorphism. 4. Security Settings (pharmacovigilance). 5. Development of PPK by bayesiona prediction model based on the results obtained from the study.;Primary end point(s): CALCINEURIN ACTIVITY (AREA UNDER THE CURVE);Timepoint(s) of evaluation of this end point: BASELINE AND 35 DAYS POST CONVERSION | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PHARMACOKINETICS OF ENVARSUS COMPARED TO PROGRAF;Timepoint(s) of evaluation of this end point: BASELINE AND 35 DAYS POST CONVERSION | — |
Countries
Spain
Contacts
Public ContactCAROLINA POLO
INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE
Outcome results
None listed