Individual assessment for Immunosuppression Minimization in transplanted patients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 669

Inclusion Criteria

1)Men and women, age =18 years.
2)Subject must be a recipient of a first renal transplant from a deceased or living donor.
3)Subject must have a current documented PRA <20% and no detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
4)Subject is willing to provide signed written informed consent.
5)Women of Childbearing Potential (WOCBP) must be using two highly effective method of contraception (Pearl-Index < 1) simultaneously to avoid pregnancy throughout the study and for 6 weeks after last MMF treatment in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial.
6)Sexually active (including vasectomised) men taking mycophenolate are willing to use condoms for sex during MMF treatment and for 90 days thereafter; partners of childbearing potential have to use highly effective contraception for the same period.
7)Subjects are willing not to donate blood during and for 6 weeks after MMF treatment, and men could not donate sperm during MMF treatment and for 90 days after stopping MMF treatment.

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 447
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

Exclusion Criteria

1)Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®).
2)CDC positive cross match.
3)Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes.
4)Cold ischemia time (CIT) higher than 24h.
5)Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT.
6)Patients previously treated with daclizumab or basiliximab.
7)Subjects with underlying renal disease of:
a.Primary focal segmental glomerulosclerosis.
b.Type I or II membranoproliferative glomerulonephritis
c.Atypical Haemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome.
8)Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive PCR result) at the moment of transplant.
9)Subjects with known human immunodeficiency virus (HIV) infection.
10)Patients with active systemic infection that requires the continued use of antibiotics.
11)Patients with neoplasia except localized skin cancer receiving appropriate treatment.
12)Patients with severe anemia (hemoglobin < 6g/dl), leucopenia (WBC <2500/mm3), thrombocytopenia (platelets <80.000/mm3).
13)Hemodynamically instable patients even if their hemoglobin level counts > 6 g/dl.
14)Patients with intestinal pathology or severe diarrhoea that can hinder absorption according to medical criteria.
15)Subjects with a known hyper sensibility to any of the drugs used in this protocol.
16)Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial.
17)WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment.
18)Subjects who are legally detained in an official institution

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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