Status:
COMPLETED
rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 composi...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04302805
Start Date
July 27 2020
End Date
June 15 2024
Last Update
August 15 2024
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine
Prague, Czechia, 140 21