NCT03867617

Brief Summary

This study investigates treatment with recipient regulatory T cells and donor bone marrow together with tocilizumab for immunomodulation in living donor kidney transplant recipients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
26mo left

Started Aug 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Aug 2019Jun 2028

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

4.9 years

First QC Date

March 6, 2019

Last Update Submit

November 27, 2024

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • Safety measured as GVHD (graft-versus-host disease), impaired graft function or patient death

    Incidence of composite safety endpoint by 12 months post-transplant.

    12 months

  • Chimerism

    Total leukocyte donor chimerism in blood.

    1 month

Study Arms (2)

Study group

EXPERIMENTAL

Treatment with regulatory T cells, donor bone marrow and tocilizumab in addition to immunosuppressive drug therapy in kidney transplant recipients

Other: Regulatory T cellsDrug: TocilizumabOther: Bone marrowProcedure: Kidney transplantOther: Immunosuppressive drug therapy

Control group

ACTIVE COMPARATOR

Immunosuppressive drug therapy without treatment with regulatory T cells, donor bone marrow and tocilizumab in kidney transplant recipients

Procedure: Kidney transplantOther: Immunosuppressive drug therapy

Interventions

Regulatory T cellsOTHER

Single infusion of expanded regulatory T cells.

Study group
TocilizumabDRUG

Treatment during first month post-transplant.

Study group
Bone marrowOTHER

Infusion of donor bone marrow cells.

Study group
Kidney transplantPROCEDURE

Living donor kidney transplantation.

Control groupStudy group
Immunosuppressive drug therapyOTHER

Immunosuppressive drug therapy.

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 blood group-compatible kidney graft.
  • Patient is a planned recipient of a kidney graft from a donor that is not HLA (human leukocyte antigen)-identical.
  • Patient is negative for DSA (donor-specific antibodies).
  • 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.

You may not qualify if:

  • Patient is EBV (epstein barr virus)-negative on serology.
  • Patient is HIV-positive or suffering from chronic viral hepatitis.
  • Patient is CMV (cytomegalo virus)-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna/Vienna General Hospital

Vienna, 1090, Austria

Location

Related Publications (1)

  • Oberbauer R, Edinger M, Berlakovich G, Kalhs P, Worel N, Heinze G, Wolzt M, Lion T, Wekerle T. 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 (Trex001). Front Med (Lausanne). 2021 Jan 27;7:634260. doi: 10.3389/fmed.2020.634260. eCollection 2020.

    PMID: 33585521DERIVED

MeSH Terms

Interventions

tocilizumabKidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Thomas Wekerle, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Transplantation Immunology

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 8, 2019

Study Start

August 1, 2019

Primary Completion

June 30, 2024

Study Completion (Estimated)

June 1, 2028

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)