Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05525507
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases
  • End Stage Kidney Disease
  • Immunological Tolerance
  • Kidney Transplant Failure and Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Conditioning and Stem cell infusion — COMBINATION_PRODUCT
    Patients will undergo a conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same HLA-identical donor that provided the original kidney

Study Details

The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).

Key Dates

Start date
Dec 21, 2022
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immune tolerance in HLA-identical kidney transplant recipient
    We seek to establish immunological tolerance in patients with a pre-existing, well- functioning kidney transplant from an HLA-identical donor. Patients will undergo conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same donor . We will evaluate whether recipients can be withdrawn from immunosuppressive drugs without compromising allograft function. At serial time points, graft function will be monitored, and chimerism will be measured. Weaning of tacrolimus will begin at 6 months, with a goal of drug discontinuation within 12 months if the following conditions are met: (1) chimerism (defined as ≥1% donor type cells among the T cells, B cells, NK cells, and granulocytes) is detectable for at least 180 days, (2) stable graft function (defined as eGFR \>30 mL/min and no greater than sustained 30% change over 3 months from baseline) without clinical rejection episodes is maintained, and (3) no evidence of graft vs. host disease (GVHD).

Primary Outcome Measure

Incidence of successful discontinuation of immunosuppression [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Jeffrey L Veale, MD
[email protected]
3102677727
Jeffrey Veale, MD (PRINCIPAL_INVESTIGATOR)
Nima Nassiri, MD (SUB_INVESTIGATOR)

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By research site
UCLA· Los Angeles, CA

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