MedTrace Logo

Tocilizumab in Cardiac Transplantation

NCT03644667 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2026-04-07

No results posted yet for this study

Summary

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

Conditions

  • Heart Transplant

Interventions

BIOLOGICAL

tocilizumab

6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.

BIOLOGICAL

Placebo

The placebo is 0.9% sterile normal saline. 6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.

DRUG

Standard of Care Triple IS

Standard of care triple maintenance IS includes: 1. A calcineurin inhibitor-tacrolimus (Prograf ®) per site standards by sublingual, oral or intravenous route to attain target trough levels. Exception: Should a participant be unable to tolerate tacrolimus, the site physician investigator may choose cyclosporine treatment. 2. An anti-proliferative treatment-mycophenolate mofetil or Myfortic® (enteric-coated mycophenolate sodium) will be administered, per protocol. Exception: Should a participant be unable to tolerate mycophenolate mofetil, the site physician investigator may choose an alternative treatment. 3. Steroids-methylprednisolone/prednisone dosing will be given according to the local center standard of practice early post transplantation. After 6 months, prednisone may be withdrawn at the discretion of the site physician investigator, per protocol.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jon A. Kobashigawa, MD · Cedars Sinai Medical Center: Transplantation

  • Joren C. Madsen, MD, DPHIL · Massachusetts General Hospital: Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2025-03-25
Completion
2025-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644667 on ClinicalTrials.gov