Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
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ClinicalTrials.gov Identifier: NCT01875224 |
Recruitment Status
: Unknown
Verified June 2013 by Bruce Kaplan, University of Arizona.
Recruitment status was: Not yet recruiting
First Posted
: June 11, 2013
Last Update Posted
: June 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
New Onset Diabetes After Transplant Kidney Transplantation | Drug: Belatacept Drug: Tacrolimus | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | August 2016 |
Estimated Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Belatacept and CellCept
Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.
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Drug: Belatacept
Other Name: Nulojix
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Active Comparator: Tacrolimus and CellCept
Tacrolimus and CellCept taken twice daily based on patient response.
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Drug: Tacrolimus
Standard administration of tacrolimus
Other Name: Prograf
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- Increased insulin sensitivity [ Time Frame: 12 months ]
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)
- Decreased insulin resistance [ Time Frame: 12 months ]
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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent must be given by patient.
- Adult patients between age 18 and 65
- Thymoglobulin induction at the time of transplant
- Patient must be Epstein-Barr Virus seropositive
Exclusion Criteria:
- Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
- Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
- History of stroke, severe cardiac disease or cardiac failure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875224
Contact: Bruce Kaplan, MD | 520-626-6371 | ||
Contact: Rochelle Byrne, RN | 520-626-9603 | rbyrne@deptofmed.arizona.edu |
United States, Arizona | |
University of Arizona | Not yet recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Rochelle Byrne, RN 520-626-9603 rbyrne@deptofmed.arizona.edu | |
Principal Investigator: Bruce Kaplan, MD |
Principal Investigator: | Bruce Kaplan, MD | University of Arizona |
Responsible Party: | Bruce Kaplan, Chief of Abdominal Transplantation, University of Arizona |
ClinicalTrials.gov Identifier: | NCT01875224 History of Changes |
Other Study ID Numbers: |
IM103-303 |
First Posted: | June 11, 2013 Key Record Dates |
Last Update Posted: | June 11, 2013 |
Last Verified: | June 2013 |
Keywords provided by Bruce Kaplan, University of Arizona:
kidney transplant diabetes after transplant belatacept |
Additional relevant MeSH terms:
Tacrolimus Abatacept Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Calcineurin Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Antirheumatic Agents |