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FDA clinical hold, IND withdrawn.
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-transplant immunosuppression | Experimental | subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation. |
|
| pre-transplant induction | Experimental | subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. |
|
| standard of care | Active Comparator | subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myfortic (mycophenolic acid) | Drug | 720mg twice a day for 7 days prior to transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction in ischemia reperfusion injury | Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| secondary outcomes | incidence of acute rejection, graft survival, patient survival, change in cylex values | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph K Melancon, MD | Georgetown University Hospital | Principal Investigator |
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| Myfortic (mycophenolic acid) | Drug | 720mg twice a day after transplant |
|
| Thymoglobulin (anti-thymocyte globulin) | Drug | up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient. |
|
| Thymoglobulin (anti-thymocyte globulin) | Drug | standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours. |
|
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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