Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation

Stopped early · Phase 2

Conditions studied: Primary Heart Transplant, Heart Transplantation, Heart Transplant

In brief

The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.

Key facts

Study ID

NCT01769443

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2

Starts

2013-06-01

Expected to finish

2014-07-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be able to understand and provide informed consent;
• Candidate (as recipient) for a primary heart transplant (single organ transplant);
• Calculated panel reactive antibody (cPRA) of greater than 30% with a threshold using mean fluorescent intensity (MFI) of 3,000 or standard fluorescence intensity (SFI) of 60,000;
• Status 1 (1A or 1B) enrollment and randomization to occur within 2 weeks after status 1 listing;
• Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse;
• Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse;
• Negative test for HIV (human immunodeficiency virus), HBsAg (hepatitis B surface antigen), HBcAb (hepatitis B core antibody), and HCV (hepatitis C virus) antibodies within 6 months prior to study entry.

You may not qualify if…

• Recipient of multiple solid organ or tissue transplants;
• Prior history of organ transplantation;
• Women of childbearing potential with a positive serum β-human chorionic gonadotropin (β-hCG) pregnancy test.Pregnancy testing is not required for postmenopausal or surgically sterilized women;
• Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow-up period;
• Subject has a hypersensitivity to VELCADE® (bortezomib), boron, or mannitol;
• Active systemic infection at time of enrollment;
• Any history of serologic positivity to HIV, HBsAg, HBcAb and HCV Ab;
• History of malignancy except when noted by an oncology specialist that tumor recurrence is low based on tumor type, response to therapy and negative metastatic work-up;
• Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy;
• Subjects with a platelet count of less than 75,000 within 7 days prior to enrollment;
• Subjects with an absolute neutrophil count (ANC) of less than 1,500 within 7 days prior to enrollment;
• Subjects with >1.5 x ULN (upper limit of normal) total bilirubin;
• Subjects with any grade or history of neuropathy;
• Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements;
• Participation in another interventional clinical trial or requiring treatment using un-marketed investigational drug(s) within 14 days of start of this trial and throughout the duration of this trial.

Where it is running

• Cedars Sinai Heart Institute — Beverly Hills, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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