Treg Modulation With CD28 and IL-6 Receptor Antagonists

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04066114
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Kidney Transplant Recipients
  • Living-Donor Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • lulizumab pegol — BIOLOGICAL
    25 mg subcutaneously (SC) on Day 1 post transplantation then 12.5 mg SC weekly through day 77 (Week 11)
  • antithymocyte globulin (rabbit) — BIOLOGICAL
    Study participants are administered four doses of rabbit anti-thymocyte globulin, total dose 6 mg/kg given in divided doses on the day of transplantation and days 1-3.
  • methylprednisolone — DRUG
    500 mg (IV) on Day 0 (day of transplantation), 250 mg (IV) on Day 1 and 125 mg (IV) on Day 2
  • tocilizumab — BIOLOGICAL
    8 mg/kg (IV) on Day 2 post transplantation followed by 162 mg (SC) every 2 weeks through day 168 (Week 24)
  • Prednisone — DRUG
    Beginning on Day 3 post transplantation, taken orally: 60 mg daily * Days 4 through 10: 30 mg daily * Days 11 through 17: 20 mg daily * Days 18 through 24: 10 mg daily * After Day 24: continued taper of dose to final maintenance dose of 5 mg, per protocol
  • everolimus — DRUG
    Initial dose of 0.75 mg taken orally twice daily on Day 14 days after transplantation. Dose will be titrated to target trough levels 3-8 ng/mL.
  • belatacept — BIOLOGICAL
    5 mg/kg (IV) every 4 weeks starting on Day 84 (Week 12) and continuing through Day 364 (Week 52)
  • mycophenolate mofetil — DRUG
    mycophenolate mofetil is started no later than one day after transplant at 1000mg PO twice daily provided WBC count permits, staying on it until everoliumus level is within therapeutic range. Participants that do no tolerate everolimus can stay on or switch back to mycophenolate mofetil 1000 mg twice daily and remain in trial.
  • mycophenolic acid — DRUG
    mycophenolic acid is started no later than one day after transplant at 720mg PO twice daily provided WBC count permits, staying on it until everoliumus level is within therapeutic range. Participants that do not tolerate everolimus can stay on or switch back to 720 mg twice daily of mycophenolic acid and remain in trial.

Study Details

The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.

Key Dates

Start date
Dec 11, 2019
Status verified
Oct 2024
Primary completion
Sep 14, 2023
Completion
Sep 14, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lulizumab pegol + novel ISR
    lulizumab pegol + novel ISR: lulizumab pegol plus immunosuppressive regimen (anti-thymocyte globulin (rabbit), steroids,) belatacept, tocilizumab, and everolimus)

Primary Outcome Measure

The Proportion of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated or Antibody-mediated Rejection (as Defined by Banff Criteria) at 6 Months Post-transplantation. [ Time Frame: 6 months post-transplantation ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama School of Medicine: TransplantationBirminghamAlabama35233-
University of California San Francisco School of Medicine: TransplantationSan FranciscoCalifornia94143-
University of Colorado (UC) Health Transplant Center - AnschutzAuroraColorado80045-
Northwestern Memorial Hospital: TransplantationChicagoIllinois60611-
University of Nebraska Medical Center: TransplantationOmahaNebraska68105-
Duke University Medical Center: TransplantationDurhamNorth Carolina27710-
Cleveland Clinic Foundation: TransplantationClevelandOhio44195-

Find similar trials in Birmingham, AL

By research site
University of Alabama School of Medicine: Transplantation· Birmingham, ALUniversity of California San Francisco School of Medicine: Transplantation· San Francisco, CAUniversity of Colorado (UC) Health Transplant Center - Anschutz· Aurora, CONorthwestern Memorial Hospital: Transplantation· Chicago, ILUniversity of Nebraska Medical Center: Transplantation· Omaha, NEDuke University Medical Center: Transplantation· Durham, NC

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