rATG Versus rATG Combined With IVIG Induction Immunosuppression in HLA Incompatible Transplantation

Eudra CT: 2019-003723-37

This study aims to prove similar efficacy of PE/rATG (intervention) and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months after HLA incompatible kidney transplantation.

2020-07-27

2024-04-15

2024-04-15

Recruiting

Early phase I

138

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study is a prospective randomized single-centre open-label two-arm Phase III.b non-inferiority clinical trial. This trial aims to prove similar efficacy of PE/rATG and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months after HLA incompatible kidney transplantation.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 138, 'type': 'ESTIMATED'}}

2024-03-06