STUDY TO OPTIMIZE IMMUNOSUPPRESSIVE MEDICATION AS A RESULT OF TWO MARKERS IN PATIENTS WHO RECEIVE A RENAL TRANSPLANTATION OF A LIVE DONOR

Phase 1

Conditions: PROPHYLAXIS OF REJECTION AFTER KIDNEY TRANSPLANTATION
MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2017-002293-39-NL

Lead Sponsor: ORIOL BESTARD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 164

Inclusion Criteria

1) Adult men and women (= 18 years).
2) Receptors of a first kidney transplant from a living donor.
3) AB0 compatible transplant.
4) Patients with a calculated PRA <= 75% by solid-phase technique and absence of current or historical donor specific class I or class II anti-HLA antibodies (DSA).
5) Patients who agree to participate in the Assay by signing the Informed Consent specific to this study.
6) Potentially fertile women should use high-reliability contraceptive methods (Pearl-Index <1) to prevent pregnancy for the duration of the study and up to 6 weeks after the end of their treatment with Mycophenolate Mofetil (MMF). Potentially Fertile Women include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhoea = 12 consecutive months, or women who are receiving hormone replacement therapy with a documented level of follicle stimulating hormone (FSH)> 35 mlU / ml). Potentially Fertile Women should have a pregnancy test with a negative result performed within 72 hours prior to the start of the trial.
7) Sexually active (including vasectomized) males who are receiving MMF treatment should accept the use of barrier contraception during MMF treatment and during the 90 days thereafter. Potentially fertile couples of these patients should use a reliable method of contraception during the same period, in order to minimize the risk of pregnancy.
8) Patients should agree not to donate blood during MMF treatment and for 6 weeks thereafter. Males should not donate sperm during MMF treatment and up to 90 days after finishing MMF.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

1) Patients with a calculated PRA > 75% by solid-phase technique and/or presence of current or historical donor specific class I or class II anti-HLA antibodies (DSA).
2) Cross Match positive result.
3) Patients receiving a graft from a deceased donor.
4) Patients who have undergone a previous solid organ transplant (including renal transplantation) or who are going to receive another solid organ transplant concomitantly.
5) Patients with any of the following basic kidney diseases:
Primary focal and segmental glomerulosclerosis
Atypical Uremic Hemolytic Syndrome (aHUS) / Thrombotic Thrombotic Syndrome Thrombocytopenic.
6) Patients with active Hepatitis B virus (HBV) infection and / or active Hepatitis C virus infection (positive PCR result) at the time of transplantation.
7) Patients with known Human Immunodeficiency Virus (HIV) infection.
8) Patients with active systemic infection requiring continued antibiotic administration.
9) Patients with any neoplasia except localized skin cancer receiving appropriate treatment.
10) Patients with severe anemia (hemoglobin <6g / dl), leukopenia (WBC <2500 / mm3) and / or thrombocytopenia (platelets <80,000 / mm3).
11) Hemodynamically unstable patients with hemoglobin levels> 6g / dl.
12) Patients with intestinal pathology or severe diarrhea that may decrease absorption according to medical criteria.
13) Patients with known hypersensitivity to any of the drugs used in this study.
14) Patients who have received any investigational drug within 30 days prior to their inclusion in this study.
15) Potentially fertile women who do not agree to use reliable contraceptive measures during the trial, who are pregnant, breastfeeding or have a positive pregnancy test at the time of enrollment.
16) Patients 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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