Study to test treatment with two types of cells for influencing the immune system in kidney transplant patients

A prospective controlled trial to evaluate safety and efficacy of in vitro expanded recipient regulatory T cell therapy and tocilizumab together with donor bone marrow infusion in HLA-mismatched living donor kidney transplant recipients (Trex) - Cell therapy for immunomodulation in kidney transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003142-16-AT

Enrollment

Registered

2018-10-12

Start date

2019-02-20

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation.

Interventions

Trade Name: RoActemra Pharmaceutical Form: Injection INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patient has provided written informed consent. ? Patient is 18 years or older. ? Patient is a planned recipient of a living donor kidney transplant. ? Patient is a planned recipient of an ABO-compatible kidney graft. ? Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical. ? Patient is negative for DSA. ? WOCBP must have a negative pregnancy test at inclusion. ? 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. 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Patient is EBV-negative on serology. Patient is HIV-positive or suffering from chronic viral hepatitis. Patient is CMV-negative and receiving a kidney from a CMV-positive donor. Positive T-cell lymphocytotoxic cross match. Patient with prior kidney transplant or non-renal solid organ transplant. Patient has a known contraindication to any of the protocol-specified treatments. 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. Female patients who are breast-feeding. Female patients with a positive pregnancy test

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective: 1) To examine the safety of Treg therapy together with tocilizumab and donor bone marrow in living donor kidney transplant recipients. 2) To assess chimerism levels within the first month post-transplant. ;Secondary Objective: 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. To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation. To assess the frequency of biopsy-proven acute rejection episodes. To assess the frequency of subclinical rejection episodes on surveillance biopsies. To assess kidney graft function. To assess the area-under-the-curve (AUC) of chimerism.;Primary end point(s): 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. Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.;Timepoint(s) of evaluation of this end point: Co-primary endpoint 1: Within the first 12 months post-transplant. Co-primary endpoint 2: Within the first month post- transplant.	—

Measure

Time frame

Main Objective: Primary Objective: 1) To examine the safety of Treg therapy together with tocilizumab and donor bone marrow in living donor kidney transplant recipients. 2) To assess chimerism levels within the first month post-transplant. ;Secondary Objective: 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. To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation. To assess the frequency of biopsy-proven acute rejection episodes. To assess the frequency of subclinical rejection episodes on surveillance biopsies. To assess kidney graft function. To assess the area-under-the-curve (AUC) of chimerism.;Primary end point(s): 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. Co-primary endpoint 2 (efficacy) is defined as the individual peak chimerism levels within the first month post-transplant.;Timepoint(s) of evaluation of this end point: Co-primary endpoint 1: Within the first 12 months post-transplant. Co-primary endpoint 2: Within the first month post- transplant.

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Secondary

Measure	Time frame
Secondary end point(s): 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. To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation. To assess the frequency of biopsy-proven acute rejection episodes. To assess the frequency of subclinical rejection episodes on surveillance biopsies. To assess kidney graft function. To assess the area-under-the-curve (AUC) of chimerism.;Timepoint(s) of evaluation of this end point: Within the first 12 months post-transplant, and within the long-term extension phase (optional; phase 1: 12-36 months post-transplant, phase 2: 36-60 months post-transplant).	—

Measure

Time frame

Secondary end point(s): 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. To gain insight as to whether the study protocol leads to detectable changes in the immune system indicative of pro-tolerogenic immune modulation. To assess the frequency of biopsy-proven acute rejection episodes. To assess the frequency of subclinical rejection episodes on surveillance biopsies. To assess kidney graft function. To assess the area-under-the-curve (AUC) of chimerism.;Timepoint(s) of evaluation of this end point: Within the first 12 months post-transplant, and within the long-term extension phase (optional; phase 1: 12-36 months post-transplant, phase 2: 36-60 months post-transplant).

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Countries

Austria

Contacts

Public ContactDepartment of Surgery

Medical University of Vienna

4314040056210

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026