Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02377193
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged from 18 to 70 years
* Recipient of a deceased or living donor kidney transplant with the following criteria:
* Incompatible grafts rate ≥ 50% for the last available serum before transplantation \< 3 months
* Anti-HLA antibodies positive
* Negative DSA by luminex method on historical serum and day serum
* T and B negative Cross match on historical and day serum
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved and reliable method of birth control for the duration of the study and for a period of 2 months after study medication discontinuation, even where there has been a history of infertility
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
* Patients affiliated to, or recipients of, a social security system
Exclusion Criteria:
* Recipients of a multi-organ transplantation, including dual kidneys, or who have previously received non renal transplanted organs
* Recipients of a kidney from non-heart beating donor, or with ABO incompatibility against the donor or with a T positive cross match
* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment
* Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin ≥ 3 upper limit of the normal range (ULN)
* Known hypersensitivity or contra-indication to rabbit proteins, basiliximab, tacrolimus, mycophenolic acid or any of the product excipients
* Patients who are Hepatitis C positive (positive PCR and normal hepatic test may be included), HIV positive, or Hepatitis B surface antigen positive (AgHBs).
* Patients with thrombocytopenia \< 75,000/mm3, an absolute neutrophils count \< 1,500/mm3, leukocytopenia \< 2,500/mm3, and/or hemoglobin \< 8g/dL at inclusion visit
* Patients with any past or present malignancy within the last five years except excised squamous or basal cell carcinoma of the skin and treated in situ cervix uteri cancer
* Any surgical or medical condition, excluding transplantation which compromise the inclusion of the patient (investigator's opinion)
* Female patients who are pregnant, breast feeding or capable to become pregnant and not wishing or capable to practice a medically approved and reliable method of birth control
* Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02377193
Study Brief:
Protocol Section:
NCT02377193