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, negative CDC prior to transplantation.
Conditions
Interventions
Trade Name: Thymoglobuline 5 mg/ml prášek pro infuzní roztok
Product Name: Thymoglobuline 5 mg/ml, prášek pro infuzní roztok
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN o
Sponsors
Institut klinické a experimentální medicíny (IKEM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Primary deceased donor or living donor kidney transplantation (first transplantation or re-transplantation) • Recipient age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: • Combined kidney transplantation with another organ • Immunosuppressive therapy up to 6 months before transplantation • AB0i transplantation • Women in childbearing potential without adequate contraception • HIV positivity • Leukopenia 5 000 known at screening prior to transplant • FACS T and B CM positivity known at screening prior to transplant • Positive CDC prior to transplantation • Planned PP/PE and RTX treatment post-transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 kidney transplantation up to 12 months post-transplantation ;Secondary Objective: •Incidence of active ABMR lesions within 12 months post-transplantation •Time to active ABMR within 12 months post-transplantation •Incidence of chronic active ABMR and C4d staining without evidence of rejection in protocol biopsies at M3 and M12 •Incidence of TG in protocol biopsies at M3 and M12 •Incidence of acute TCMR and chronic active TCMR in protocol biopsies at M3 and M12 post-transplantation •eGFR at M3, M6 and M12 •Measured proteinuria and albuminuria at M3, M6 and M12 •DSA at M3, M6 and M12 •De novo DSA at M3, M6 and M12 •Mortality rate within 12 months post-transplantation •Graft survival (rate of graft loss) within 12 months post transplantation •Incidence of metabolic, malignant and cardiovascular co-morbidities •Incidence of viral and bacterial complications •Incidence of BKV, CMV and EBV replications detected by PCR at M3, M6 and M12 •Incidence of study treatment discontinuation;Primary end point(s): 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 kidney transplantation up to 12 months post-transplantation ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of active ABMR lesions within 12 months post-transplantation • Time to active ABMR within 12 months post-transplantation • Incidence of chronic active ABMR and C4d staining without evidence of rejection in protocol biopsies at M3 and M12 • Incidence of TG in protocol biopsies at M3 and M12 • Incidence of acute TCMR and chronic active TCMR in protocol biopsies at M3 and M12 post-transplantation • eGFR at M3, M6 and M12 • Measured proteinuria and albuminuria at M3, M6 and M12 • DSA at M3, M6 and M12 • De novo DSA at M3, M6 and M12 • Mortality rate within 12 months post-transplantation • Graft survival (rate of graft loss) within 12 months post transplantation • Incidence of metabolic, malignant and cardiovascular co-morbidities • Incidence of viral and bacterial complications • Incidence of BKV, CMV and EBV replications detected by PCR at M3, M6 and M12 • Incidence of study treatment discontinuation;Timepoint(s) of evaluation of this end point: 3 months, 6 months or 12 months | — |
Countries
Czech Republic
Contacts
Public ContactProf. Ondrej Viklický, M.D., Ph.D.
Institut klinické a experimentální medicíny (IKEM)
Outcome results
None listed