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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04302805
Eligibility Criteria:
Inclusion Criteria:
* Primary deceased donor or living donor kidney transplantation (first transplantation or re-transplantation)
* Recipient age ≥ 18 years and \< 70 years
* Donor age \< 70 years
* Written Informed Consent and Consent for Processing Personal Data
* Last anti-HLA screening no longer than 12 months with positive results
* MFI DSA 1 000 - 5 000 (anti-HLA A, B, DR), MFI DSA 1000-15000 for anti DQ when available at randomization)
Exclusion Criteria:
* Combined kidney transplantation with another organ
* Immunosuppressive therapy up to 6 months before transplantation
* AB0i (AB0 incompatible) transplantation
* Women in childbearing potential without adequate contraception
* HIV positivity
* Leukopenia \< 3 000, thrombocytopenia \< 75 000
* Tuberculosis history
* Anti-HCV (Hepatitis C Virus) positivity, HBsAg (Hepatitis B Surface Antigen) positivity or HBV (Hepatitis B Virus) DNA positivity
* DSA (anti A, B, DR) measured by Luminex with MFI \> 5 000 known at screening prior to transplant, anti DQ \> 15000 if known
* FACS (flow-cytometry) T and B crossmatch positivity known at screening prior to transplant
* Positive CDC prior to transplantation
* Planned PP/PE and RTX (Rituximab) treatment post-transplant
* Advanced liver disease (Child-Pugh C or laboratory values of ALT or AST more than 3 times upper limit of normal range)
* Pregnancy, breastfeeding
* Study medication is contraindicated according to the SmPC
* Patient is enrolled in other clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04302805
Study Brief:
Protocol Section:
NCT04302805