Assessment of long term minimization of immunosuppression in transplanted patients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

1. Primary deceased-donor or living-donor kidney transplantation
2. Men and women (recipient) age >18 years and <70 years
3. Panel reactive antibody frequency/ calculated panel reactive antibody frequency (peak PRA/cPRA) <20%
4. Written informed consent
5. Diagnosis of end stage renal disease
6. Women of Childbearing Potential (WOCBP) must be using a highly effective method of contraception (Pearl-Index < 1) to avoid pregnancy throughout the study 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. Male participants with pregnant or non-pregnant WOCBP partner must use condoms.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Previous transplantation
2. Combined kidney transplantation with other organ
3. Subjects receiving an allograft from a donor older than 65 years with elevated serum creatinine levels and/or treated diabetes.
4. Immunosuppressive therapy up to 6 months before transplantation
5. Planned induction therapy with depletion agents
6. EBV seronegativity
7. HIV positivity
8. Leukopenia < 3000 cells per microliter, thrombocytopenia < 100 000 cells per microliter
9. Biological therapy history with ATG, OKT3, anti TNF agents
10. Tuberculosis history
11. Cancer history (skin non-melanoma cancer excluded)
12. Anti HCV positivity, HBsAg positivity or HBV DNA positivity
13. Detectable donor specific antibodies (DSA) by solid phase assay (Luminex®)
14. Subjects with a known hypersensibility to any of the drugs used in this protocol
15. Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial
16. 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
17. Subjects who are legally detained in an official institution
18. All contraindications against study medication (including auxiliary substances)
19. Interactions with study medication
20. Current treatment with one of the following substances: cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, rituximab, prednisone
21. Patients unwilling to consent to saving and propagation of pseudonymized medical data and/or biological samples for study reasons
22. Chronic heart failure (NYHA III, IV) at transplantation
23.Participation in other clinical trials (pharmaceutical trials)
24. persons dependent of the sponsor, investigator or investigative site
25. positive Quantiferon test (for TBC)
26. live vaccine treatment 30 days prior to enrolment in this clinical trial

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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