A study to evaluate the effect of a new medicine (Envarsus) compared tomedicines used in current practice in new kidney transplant patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 445

Inclusion Criteria

Patient’s signed informed consent obtained prior to any study-related procedure;
2.Adult men and women at least 18 years of age with end-stage renal disease who are recipients of a kidney transplant from a living or deceased donor;
No known contraindications to the administration of tacrolimus and study drugs excipients;
4.Patients must agree to use a highly reliable method of birth control;
5. Donor-recipient negative cross match test, and compatible ABO blood type;
6. Able to swallow tablets and capsules.

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 356
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 89

Exclusion Criteria

1.Recipient of any transplanted organ other than kidney;
2.Recipient of a previous renal transplant;
3.Recipient of a kidney from a donor after cardiac death;
4.Recipient of a kidney from an ABO incompatible or positive cross-match donor;
5.Current anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%;
6.Recipient of a kidney with a cold ischemia time of = 30 hours;
7.White blood cells count = 2.8x109 cells/L unless ANC >1.0x109/L;
8.Platelet count < 50 x109 cells/L;
9.ALT or AST levels >3 times the normal upper limit during the 30 days prior transplant procedure;
10.Current abuse of drugs or alcohol;
11.Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;
12.Treatment with any other investigational agent in the 30 days prior to enrolment;
13.Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);
14.Kidney recipients and/or donors positive for HBV (HBV-DNA or HBS-Ag positive);
15.Recipients positive for HIV;
16.Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;
17.Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;
18.Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;
19.Known hypersensitivity to tacrolimus;
20.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 following reliable methods of contraception:
a. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
b. Hormonal contraception (implantable, injectable, patch, oral)
c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical vaults/caps) with spermicidal foam/gel/film/cream/suppository
d. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
Reliable contraception should be maintained throughout the study until last study visit.
True abstinence” is acceptable only if it is in line with the preferred and usual lifestyle of the patient.
Pregnancy testing will be carried out in all women of childbearing potential at screening, transplantation day and end of treatment.
Any postmenopausal women (physiologic menopause defined as 12 consecutive months of amenorrhea”) or women permanently sterilized (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) can be enrolled in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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