rATG versus rATG combined with IVIG induction immunosuppression in HLA incompatible transplantatio

Phase 1

• Conditions: 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.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-003723-37-CZ
• Lead Sponsor: Institut klinické a experimentální medicíny (IKEM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 138

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, 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

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 < 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified