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

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ClinicalTrials.gov Identifier: NCT01769443
Recruitment Status : Terminated (Inability to enroll within funding period)
First Posted : January 16, 2013
Results First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Heart Transplant
Heart Transplantation
Heart Transplant
Interventions Drug: bortezomib
Procedure: plasmapheresis
Enrollment 2
Recruitment Details The study planned to enroll 80 participants; however, the decision to terminate the study was made due to the very slow rate of participant accrual and the inability to meet the recruitment goal within the funding period. Only 2 participants were enrolled at one site before study recruitment status changed to "Active, not recruiting."
Pre-assignment Details  
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Period Title: Overall Study
Started 1 1
Completed 0 1
Not Completed 1 0
Reason Not Completed
Study closure             1             0
Arm/Group Title No Desensitization Desensitization Total
Hide Arm/Group Description No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
All enrolled
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
0
   0.0%
1
  50.0%
>=65 years
0
   0.0%
1
 100.0%
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
0
   0.0%
1
  50.0%
Male
0
   0.0%
1
 100.0%
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
1
 100.0%
1
 100.0%
2
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Composite of Incidence of the Following Events in Subjects
Hide Description
  • Death,
  • Removal from the transplant waiting list for any reason except improvement of cardiac function,
  • Initiation of any mechanical circulatory support device,
  • Severe infection requiring intravenous antibiotics,
  • Cerebral vascular accident,
  • Acute renal failure requiring dialysis.
Time Frame At transplant, or 90 days post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time From Wait Listing to Heart Transplantation
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Calculated PRA (cPRA) From Wait Listing to Transplantation
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Incidence of Death
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Incidence of Initiation of Any Mechanical Circulatory Support Device
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Incidence of Severe Infection Requiring Intravenous Antibiotics
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Incidence of Cerebral Vascular Accident
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Incidence of Acute Renal Failure Requiring Hemodialysis
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization
Hide Description [Not Specified]
Time Frame At transplant, or 1 year post-randomization, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing.
Hide Description [Not Specified]
Time Frame 24 and 52 weeks:
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD)
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Death
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Re-transplantation or Re-listed for Transplantation
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Incidence of Hospitalizations
Hide Description [Not Specified]
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Incidence of Rejection Episodes Per Subject and Freedom From Rejection
Hide Description

Rejection is defined as follows:

  • Biopsy proven acute rejection (BPAR) of any grade (cellular rejection per 2004 ISHLT [International Society of Heart and Lung Transplantation] grading scale),
  • BPAR (individual grades),
  • BPAR (Biopsy Proven Acute Rejection) > 2R
  • antibody mediated rejection (AMR),
  • Any treated rejection,
  • Rejection associated with hemodynamic compromise (HDC).
Time Frame 24 and 52 weeks post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were performed due to slow enrollment and early study closure.
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description:
No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from the time of the first protocol mandated procedure until the study completion, or until 30 days after the subject prematurely withdraws from the study.
Adverse Event Reporting Description The participant randomized to the control arm ("No Desensitization Therapy") completed week 24 (6 months) of post-transplantation evaluations. The participant assigned to the Investigational Arm ("Desensitization Therapy") completed week 52 (12 months) of post-transplantation follow-up.
 
Arm/Group Title No Desensitization Desensitization
Hide Arm/Group Description No desensitization therapy pre-transplantation

Plasmapheresis with concomitant bortezomib.

  • Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.
  • Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib
All-Cause Mortality
No Desensitization Desensitization
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
No Desensitization Desensitization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Desensitization Desensitization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/1 (0.00%)    
Injury, poisoning and procedural complications     
compression fracture  1  1/1 (100.00%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 15.1
Study was terminated by the study sponsor, with agreement from the investigators. Reason: very slow rate of accrual and inability to meet the accrual goal within the funding period. (N=2 enrolled. Aim was 80 participants).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01769443    
Other Study ID Numbers: DAIT CTOT-13
U01AI063594 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: October 13, 2015
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015