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Monoclonal Antibodies
Tocilizumab in Cardiac Transplantation
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
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 moreSide effects data
From 2012 Phase 4 trial • 91 Patients • NCT0116374710%
Upper respiratory tract infection
6%
Nasopharyngitis
6%
Urinary tract infection
3%
Sinusitis
3%
Nausea
3%
Cellulitis
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,634 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,191 Total Patients Enrolled
PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,115 Total Patients Enrolled
Jon A. Kobashigawa, MDStudy ChairCedars Sinai Medical Center: Transplantation
1 Previous Clinical Trials
66 Total Patients Enrolled
Joren C. Madsen, MD, DPHILPrincipal InvestigatorMassachusetts General Hospital: Transplantation