Conversion study in renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day.

• Conditions: REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS; MedDRA version: 18.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-005275-24-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-17
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified