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| ID | Type | Description | Link |
|---|---|---|---|
| 2013H0312 | Other Identifier | The Ohio State University Wexner Medical Center |
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Drug unavailability due to a manufacturing transition.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept | Active Comparator | Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study. |
|
| Everolimus | Active Comparator | Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug |
|
| |
| Everolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recover from Delayed Graft Function | For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent patients reaching recovery (defined above) by 14 days and 3 months. | Percent patients reaching recovery (defined above) by 14 days and 3 months. | Assessed at 3, 6, 12 months |
| Hospital length of stay (days) from date of transplant to discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Von Visger, M.D./Ph.D. | OSU Wexner Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Universtiy Wexner Medical Center | Columbus | Ohio | 43212 | United States |
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Drug |
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by monitoring patient while inpatient
| up to 7 days |
| Number of dialysis treatments | by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Number of biopsies | medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period | Assessed at 3, 6, 12 months |
| Biopsy proven acute rejection events | by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Patient and graft survival | by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Number of hospital readmissions | by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Detection of DSA (Luminex) | by blood draw | Assessed at 3, 6, 12 months |
| Incidence and type of infection | by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Measured or estimated creatinine clearance. | by blood draw | Assessed at 3, 6, 12 months |
| Banff score of rejection episodes and immune suppression treatment/management of rejection | by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored). | by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's | Assessed at 3, 6, 12 months |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |