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

Kidney Transplantation Clinical Trial

Official title:
rATG Versus rATG Combined With IVIG Induction Immunosuppression in HLA Incompatible Transplantation

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04302805
Study type Interventional
Source Institute for Clinical and Experimental Medicine
Contact Ondrej Viklicky, Prof.
Phone +420 261364110
Email ondrej.viklicky@ikem.cz
Status Recruiting
Phase Phase 3
Start date July 27, 2020
Completion date April 15, 2024
View Details
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