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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    138
  • sponsor
    Institute for Clinical and Experimental Medicine
Updated on 13 April 2021

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.

Description

There have been no published clinical studies evaluating rATG/IVIG induction protocol in comparison with rATG alone in defined cohort of HLA incompatible kidney transplant recipients. Prescribing IVIG in management of prevention of transplant rejection is considered off-label use, however IVIG remains part of induction protocols in many transplant centres. IVIG therapy is demanding due to high cost and limited resources of these human origin products. Trial participants will be end-stage renal disease (ESRD) patients listed for deceased donor / living donor kidney transplantation with anti HLA antibody screening performed within 12 months before transplantation and with last DSA 1 000 - 5 000 Mean Fluorescence Intensity (MFI) and negative CDC (Complement-dependent cytotoxicity crossmatch test) prior to transplantation. Participants will be randomized into one of the treatment groups (PE/PP(Plasmapheresis) + rATG + IVIG, PE/PP + rATG) and as a primary outcome a composite endpoint defined as occurrence of antibody- or T-cell mediated rejection within 12 months after transplantation will be evaluated.

Details
Condition Organ Transplantation, Organ Transplant, Organ Transplant - Pediatric, Renal transplant, Kidney Transplantation, Organ Transplant - Pediatric, Organ Transplant, Kidney Transplantation, kidney transplant, renal transplantation, kidney transplants
Treatment Thymoglobulin, Plasma Exchange, Privigen
Clinical Study IdentifierNCT04302805
SponsorInstitute for Clinical and Experimental Medicine
Last Modified on13 April 2021

Eligibility

Yes No Not Sure

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
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