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belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.
A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| converted to a belatacept based immunosuppression | Belatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversion to a belatacept regimen | Drug | belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allograft survival after conversion to belatacept | Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft. | 5 years |
| Patient survival after conversion to belatacept | Patient survival after conversion to a belatacept regimen | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients converted to a belatacept regimen after kidney transplant
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Loupy, MD, PhD | Paris Translational Research Center for Organ Transplantation | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38265815 | Derived | Divard G, Aubert O, Debiais-Deschamp C, Raynaud M, Goutaudier V, Sablik M, Sayeg C, Legendre C, Obert J, Anglicheau D, Lefaucheur C, Loupy A. Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2024 May 1;19(5):628-637. doi: 10.2215/CJN.0000000000000411. Epub 2024 Feb 22. |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |