| Primary | Composite of Incidence of the Following Events in Subjects |
- 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.
| No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 90 days post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Time From Wait Listing to Heart Transplantation | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Change in Calculated PRA (cPRA) From Wait Listing to Transplantation | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Death | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Initiation of Any Mechanical Circulatory Support Device | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Severe Infection Requiring Intravenous Antibiotics | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Cerebral Vascular Accident | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Acute Renal Failure Requiring Hemodialysis | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | At transplant, or 1 year post-randomization, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing. | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks: | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD) | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Death | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Re-transplantation or Re-listed for Transplantation | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Hospitalizations | | No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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| Secondary | Incidence of Rejection Episodes Per Subject and Freedom From Rejection | 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).
| No analyses were performed due to slow enrollment and early study closure. | Posted | | | | | | 24 and 52 weeks post-transplantation | | | | ID | Title | Description |
|---|
| OG000 | No Desensitization | No desensitization therapy pre-transplantation | | OG001 | Desensitization | 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
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