Tocilizumab in Cardiac Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

385

Participants

Timeline

Start Date

December 20, 2018

Primary Completion Date

March 21, 2025

Study Completion Date

March 21, 2025

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 After 6 months, prednisone may be withdrawn at the discretion of the site physician investigator, per protocol."

Trial Locations (20)

10029

Mount Sinai Medical Center (NYMS), New York

10032

Columbia University Medical Center (NYCP), New York

10467

Montefiore Medical Center (NYMA), The Bronx

15212

Allegheny General Hospital (PAAG), Pittsburgh

17033

Penn State Health: Milton S. Hershey Medical Center (PAHE), Hershey

19104

Hospital of the University of Pennsylvania (PAUP), Philadelphia

27710

Duke University Medical Center (NCDU), Durham

33606

Tampa General Hospital (FLTG), Tampa

37232

Vanderbilt University Medical Center (TNVU), Nashville

44195

Cleveland Clinic Foundation (OHCC), Cleveland

60611

Northwestern Memorial Hospital (INLM), Chicago

64111

St. Luke's Hospital of Kansas City (MOLH), Kansas City

68198

University of Nebraska Medical Center (NEUN), Omaha

75246

Baylor University Medical Center (TXTX), Dallas

84132

University of Utah (UTMC), Salt Lake City

90211

Cedars Sinai Medical Center (CACS), Beverly Hills

92037

University of California, San Diego: Sulpizio Cardiovascular Center (CASD), La Jolla

94305

Stanford Health Care (CASU), Stanford

02111

Tufts Medical Center (MANM), Boston

02114

Massachusetts General Hospital (MAMG), Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03644667 - Tocilizumab in Cardiac Transplantation | Biotech Hunter | Biotech Hunter