rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in H… (NCT04302805) | Clinical Trial Compass
CompletedPhase 3
rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)
Czechia17 participantsStarted 2020-07-27
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Combined endpoint defined as biopsy proven antibody mediated changes (Banff 2017, Category 2) and/or TCMR (Banff 2017, Category 4) regardless the biopsy indication (for cause or protocol biopsy) in HLAi (HLA incompatible)kidney transplantation
Timeframe: 12 months
Trial details
NCT IDNCT04302805
SponsorInstitute for Clinical and Experimental Medicine