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Monoclonal Antibodies

tocilizumab for Heart Transplant

Phase 2

Waitlist Available

Led By Joren C. Madsen, MD, DPHIL

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (4 to 8 weeks post-transplant), 1 year post-transplant

Awards & highlights

All Individual Drugs Already Approved

Approved for 50 Other Conditions

Summary

This trial is testing if Tocilizumab, a drug that reduces inflammation, can help heart transplant patients by lowering the risk of rejection. The study focuses on heart transplant recipients and aims to see if blocking a specific protein can improve their outcomes. Tocilizumab might block detrimental effects of this protein on transplantation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (4 to 8 weeks post-transplant), 1 year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (4 to 8 weeks post-transplant), 1 year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (4 to 8 weeks post-transplant), 1 year post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group

Secondary study objectives

Angiographic Evidence of Cardiac Allograft Vasculopathy (CAV) - by Treatment Group

Change in Intravascular Ultrasound (IVUS) Measurements From Baseline to 1 Year Post-Transplant- by Treatment Group

Freedom from Acute Cellular Rejection (ACR) ≥ International Society of Heart and Lung Transplantation (ISHLT) 2R Per Patient - by Treatment Group

+19 more

Side effects data

From 2012 Phase 4 trial • 91 Patients • NCT01163747

10%

Upper respiratory tract infection

Nasopharyngitis

Urinary tract infection

Sinusitis

Nausea

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Methotrexate

Tocilizumab + Methotrexate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tocilizumab + Standard of Care Triple ISExperimental Treatment2 Interventions

Tocilizumab plus standard of care triple immunosuppression (IS). Heart transplant recipients will receive tocilizumab (Actemra®) plus standard triple maintenance immunosuppression. Standard of care triple maintenance immunosuppression includes: * a calcineurin inhibitor (tacrolimus), * an anti-proliferative treatment (mycophenolate mofetil) or Myfortic® (enteric-coated mycophenolate sodium), and * steroids (methylprednisolone/prednisone) as prescribed by site physician investigator. Participants enrolled in the study will be followed for 24 months after their transplant surgery. Randomization will occur once a participant has weaned from cardiopulmonary bypass and has achieved hemodynamic stability without significant ongoing bleeding within the first 72 hours after transplant.

Group II: Placebo + Standard of Care Triple ISPlacebo Group2 Interventions

Placebo plus standard of care triple maintenance immunosuppression (IS). Heart transplant recipients will receive placebo plus standard triple maintenance immunosuppression. Standard of care triple maintenance immunosuppression includes: * a calcineurin inhibitor (tacrolimus), * an anti-proliferative treatment (mycophenolate mofetil) or Myfortic® (enteric-coated mycophenolate sodium), and * steroids (methylprednisolone/prednisone) as prescribed by site physician investigator. Participants enrolled in the study will be followed for 24 months after their transplant surgery. Randomization will occur once a participant has weaned from cardiopulmonary bypass and has achieved hemodynamic stability without significant ongoing bleeding within the first 72 hours after transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

FDA approved

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