rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)

• Status: Recruiting
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Thymoglobulin

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