rATG versus rATG combined with IVIG induction immunosuppression in HLA incompatible transplantation - INHIBIT study

Institut klinické a experimentální medicíny (IKEM)0 个研究点目标入组 138 人开始时间: 2019年10月29日最近更新: 2024年1月15日

适应症

试验速览

暂无简介。

•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, DQ only when DQ donor and recipient alleles typing are available at randomization)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 124
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•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 < 3 000, thrombocytopenia < 75 000
•Tuberculosis history
•Anti-HCV positivity, HBsAg positivity or HBV DNA positivity
•DSA measured by Luminex with MFI > 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

发起方

Institut klinické a experimentální medicíny (IKEM)