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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belatacept and CellCept | Experimental | Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily. |
|
| Tacrolimus and CellCept | Active Comparator | Tacrolimus and CellCept taken twice daily based on patient response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belatacept | Drug |
|
| |
| Tacrolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Increased insulin sensitivity | Increase in insulin sensitivity (HOMA-S) as calculated below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI * FPG) | 12 months |
| Decreased insulin resistance | Decreased insulin resistance (HOMA-IR) as measured below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA IR (insulin resistance) is calculated as (FIRI * FPG) / 22.5 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruce Kaplan, MD | Contact | 520-626-6371 | ||
| Rochelle Byrne, RN | Contact | 520-626-9603 | rbyrne@deptofmed.arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bruce Kaplan, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Drug |
Standard administration of tacrolimus |
|
|
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |