REGTIVEX for Kidney transplantation

Inclusion criteria

• {"criterion_text":"- For recipients (study and control group): Patient has provided written informed consent.\n- For donors (study group only): Participant is 18 years or older.\n- For donors (study group only): Participant is suitable to donate bone marrow according to the guidelines of the Department of Blood Group Serology and Transfusion Medicine.\n- For donors (study group only): WOCBP must not be pregnant at inclusion (i.e. negative pregnancy test).\n- For donors (control group only): Participant has provided written informed consent to donate blood for immune monitoring analyses.\n- For donors (control group only): Participant is 18 years or older.\n- For recipients (study and control group): Patient is 18 years or older.\n- For recipients (study and control group): Patient is a planned recipient of a living donor kidney transplant.\n- For recipients (study and control group): Patient is a planned recipient of an ABO-compatible kidney graft.\n- For recipients (study and control group): Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical.\n- For recipients (study and control group): Patient is negative for DSA.\n- For recipients (study and control group): WOCBP must have a negative pregnancy test at inclusion.\n- For recipients (study and control group): WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.\n- For donors (study group only): Participant has provided written informed consent."}

Exclusion criteria

• {"criterion_text":"- For recipients (study and control group): Patient is EBV-negative on serology.\n- For recipients (study and control group): Patient is HIV-positive or suffering from chronic viral hepatitis.\n- For recipients (study and control group): Patient is CMV-negative and receiving a kidney from a CMV-positive donor.\n- For recipients (study and control group): Positive T-cell lymphocytotoxic cross match.\n- For recipients (study and control group): Patient with prior kidney transplant or non-renal solid organ transplant.\n- For recipients (study and control group): Patient has a known contraindication to any of the protocol-specified treatments\n- For recipients (study and control group): Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.\n- For recipients (study and control group): Female patients who are breast-feeding.\n- For recipients (study and control group): Female patients with a positive pregnancy test."}

Primary endpoints

• {"endpoint_text":"- Co-primary endpoint 1 (safety) is defined as incidence of GVHD, impaired graft function [eGFR <35mL/min/1.73m2] or patient death, whichever occurs first, within 12 months post-transplant.","definition_or_measurement_approach":"Incidence of graft-versus-host disease (GVHD), impaired graft function defined as eGFR <35 mL/min/1.73 m2, or patient death, measured as occurrence within 12 months post-transplant."}
• {"endpoint_text":"- Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.","definition_or_measurement_approach":"Individual peak chimerism levels measured within the first month post-transplant (measurement approach not further specified in source)."}

Secondary endpoints

• {"endpoint_text":"- To demonstrate that the study protocol allows the initiation of a step-wise reduction of immunosuppression up to a point when patients receive drug monotherapy.","definition_or_measurement_approach":"As stated; measurement approach not specified in source."}
• {"endpoint_text":"- To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation.","definition_or_measurement_approach":"As stated; measurement approach not specified in source."}
• {"endpoint_text":"- To assess the frequency of biopsy-proven acute rejection episodes.","definition_or_measurement_approach":"Frequency of biopsy-proven acute rejection episodes (assessment method not specified)."}
• {"endpoint_text":"- To assess the frequency of subclinical rejection episodes on surveillance biopsies.","definition_or_measurement_approach":"Frequency of subclinical rejection episodes detected on surveillance biopsies (assessment method not specified)."}
• {"endpoint_text":"- To assess kidney graft function.","definition_or_measurement_approach":"Assessment of kidney graft function (specific measures not detailed)."}
• {"endpoint_text":"- To assess the area-under-the-curve (AUC) of chimerism.","definition_or_measurement_approach":"Area-under-the-curve (AUC) of chimerism over time (specific assay/method not detailed)."}

Austria

Earliest CTIS Part Ii Submission Date

02-05-2024

Latest Decision Or Authorization Date

31-05-2024

Processing Time Days

29

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria