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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
Is a candidate for a primary heart transplant (listed as a heart transplant only);
No desensitization therapy prior to transplant;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (4 to 8 weeks post-transplant), 1 year post-transplant
Awards & highlights

Study Summary

This trial is testing whether adding the drug tocilizumab to standard anti-rejection drugs can improve heart transplant outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently being considered for a heart transplant.
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You cannot have received desensitization therapy before the transplant.
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You agree to use a highly effective form of birth control during the study, as recommended by the FDA.
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It's okay if you have been using medical devices or participating in a drug trial that will end before the transplant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group
Secondary outcome measures
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
6%
Urinary tract infection
6%
Nasopharyngitis
3%
Nausea
3%
Cellulitis
3%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Methotrexate
Tocilizumab + Methotrexate

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?

PPDIndustry Sponsor
158 Previous Clinical Trials
36,583 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,806 Total Patients Enrolled
Joren C. Madsen, MD, DPHILPrincipal InvestigatorMassachusetts General Hospital: Transplantation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has tocilizumab received the sign-off from the FDA?

"Our team has evaluated tocilizumab's safety and judged it a 2 because of the Phase 2 trial status. This indicates that there is some data attesting to its security but no evidence demonstrating efficacy."

Answered by AI

How many hospitals and other medical facilities are offering this trial?

"Patients can be accepted into this clinical trial at numerous facilities, including Massachusetts General Hospital (MAMG) in Boston, MA, University of California San Diego: Sulpizio Cardiovascular Center (CASD) in La Jolla, CA., and Cedars Sinai Medical Center (CACS) in Beverly Hills FL. Additionally there are 18 other locations that may accept patients as well."

Answered by AI

Could you please detail the previous experiments conducted utilizing tocilizumab?

"Presently, a total of 655 tocilizumab-related studies are in progress - with 146 being in late clinical trials. Philadelphia is the hotspot for these projects; however there are nearly 20,000 other sites running experiments related to this drug."

Answered by AI

Is enrollment still available for this research endeavor?

"At present, this clinical trial is not enrolling any new participants. It was initially posted on December 20th 2018 and most recently updated on March 12th 2021. However, there are 10 studies actively recruiting cardiac transplant patients alongside an additional 655 tocilizumab trials seeking enrollees."

Answered by AI

Does this study accommodate individuals over 25 years of age?

"The parameters of eligibility for this medical trial stipulate that the minimum age to participate is 18 and the ceiling age is 75."

Answered by AI

How many subjects are taking part in the experiment?

"No longer accepting applicants, this trial was first posted on December 20th 2018 and the last update occurred 3rd of March 2021. If you are still looking for trials to enrol in, 10 cardiac transplant studies and 655 tocilizomab clinicals are currently recruiting patients."

Answered by AI

What are the eligibility requirements for participating in this clinical experiment?

"This clinical trial is seeking 200 cardiac transplant recipients, aged between 18 and 75. In order for one to be eligible for the study they must adhere to a few conditions such as ascertaining an appropriate contraception method if applicable, being vaccinated against certain diseases when there are no contraindications, not undergoing any desensitization therapy prior to their heart transplantation."

Answered by AI

For what medical purposes is tocilizumab prescribed?

"Tocilizumab is an approved therapy for scalp structure, thyroiditis, dermatitis and other forms of atopic conditions."

Answered by AI
~32 spots leftby Mar 2025