Health TrialsbyHealthPanel

Tocilizumab in Lung Transplantation

ConditionLung Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

This is a trial in which 100 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids).

The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) development of de novo donor specific antibodies (DSA), c) acute cellular rejection ≥A2, d) listed for re-transplantation, and e) death

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject and/or parent guardian must be able to understand the purpose of the study and willing to participate and sign informed consent/assent

Greater than or equal to 30 kg body weight

Listed or received for a primary lung transplant

No previous or planned desensitization therapy prior to transplant

Disqualifiers

Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)

Prior history of allogeneic organ or cellular transplantation

Received treatment to deplete Human Leukocyte Antigens (HLA) antibodies before transplantation

Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tocilizumab

    Drug

    The initial dose of tocilizumab will be administered in the operating room before reperfusion of the first lung during the lung transplant surgery. 6 doses will be given once every four weeks over a 20-week period. The dose is approved for pediatric patients who weigh 30 kg or more

  • Placebo for Tocilizumab

    Drug

    Placebo 0.9% Sodium Chloride Injection USP (Normal Saline) Placebo will be given as a single intravenous dose, volume matched to tocilizumab. Placebo will be administered over a period of approximately 60 minutes; once every four weeks over a 20-week period. The first placebo dose will be during the transplant surgery before reperfusion of the first lung allograft, with 5 subsequent monthly doses

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tocilizumab GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to 36 months

1. The development of Chronic Lung Allograft Dysfunction (CLAD) * The development of any form of CLAD will be defined according to the standard 2019 The International Society for Heart and Lung Transplantation (ISHLT) criteria. 2. The development of de novo donor specific antibodies (DSA) 3. Acute cellular rejection ≥A2 (inclusive of study mandated biopsy at 12 months post-transplant and any clinically indicated biopsy up to 1 year after randomization) 4. Listed for re-transplantation * Re-transplantation defined as the subject has been formally registered on the United Network for Organ Sharing (UNOS) waiting list to undergo a second lung transplant surgery 5. Death

Time frame
Over a period of 1 year after randomization

Secondary outcomes

1

Time to the onset of each of ACR grade ≥A2, de novo DSA, CLAD, being listed for re-transplantation, or death

Time frame
At 1 year after randomization
2

Cumulative incidence of Chronic Lung Allograft Dysfunction (CLAD)

Time frame
At 1 year after randomization
3

Cumulative incidence listed for re-transplantation

Time frame
At 1 year after randomization
4

Cumulative incidence of ACR grade ≥A2

Time frame
At 1 year after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Source ClinicalTrials.gov
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