Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:06 AM
Study NCT ID:
NCT01953120
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2013-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Mechanisms of Belatacept (Nulojix) Effect on Alloimmunity and Antiviral Response After Kidney Transplantation - (BMS Study# IM 103-309)
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research evaluates the effectiveness of a new drug called belatacept (Nulojix) for the prevention of acute rejection and preservation of kidney function in transplant patients. Belatacept was approved in 2011 by the United States Food and Drug Administration (FDA) and is being marketed as Nulojix. The pharmaceutical company sponsoring this study is Bristol-Myers Squibb.
Belatacept is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Transplant rejection happens when the body's immune system senses that the new transplanted kidney is different or foreign, and attacks it. Belatacept is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney.
The purpose of the research is to understand whether the new drug, belatacept, is better than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in the treatment against kidney rejection in transplant patients.
Belatacept is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Transplant rejection happens when the body's immune system senses that the new transplanted kidney is different or foreign, and attacks it. Belatacept is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney.
The purpose of the research is to understand whether the new drug, belatacept, is better than other anti-rejection drugs, such as cyclosporine and tacrolimus that are typically used in the treatment against kidney rejection in transplant patients.
Detailed Description:
Research Hypothesis: Switching to a belatacept-based immunosuppression regimen after kidney transplant will have a significant impact on antibody and T cell-mediated immune response as compared with control patients as measured in peripheral blood at 6 months after belatacept switch and comparable safety and efficacy as compared with calcineurin inhibitor (CNI) based regimens.
Primary Objective: To analyze the effect of switching from CNI to belatacept in patients with evidence of CNI toxicity on the development and maintenance of immune memory in response to both alloantigen and viral antigens commonly encountered after transplant, and to assess the safety and efficacy of conversion to belatacept as maintenance immunosuppression in combination with prednisone and mycophenolate mofetil.
Study Design: Open label, single center clinical trial. Patients with evidence of CNI toxicity will be eligible for switch to belatacept-based regimen within the first three months after transplant. All enrolled subjects will also receive concomitant maintenance immunosuppression with mycophenolate mofetil and corticosteroids.
Duration of Study: 6 months, with option to extend to 12 months of belatacept treatment Number of Subjects: 20 Study Population: Kidney transplant recipients within the first three months of their first transplant with evidence of CNI toxicity.
Test Product, Dose and Mode of Administration, Duration of Treatment: Study patients will receive intravenous belatacept at 5mg/kg every two weeks at day 1 and weeks 2, 4, 6, and 8, and then monthly at months 3, 4, and 5. At month 6 patients may elect to continue for an additional six month period of belatacept administration. Peripheral blood mononuclear cells (PBMCs) and sera for antibody testing will be collected at time of study entry and at 4, 8, 12, and 24 weeks after belatacept start, frozen and banked at our center, and analyzed in batch fashion for development of humoral and cell mediated immunity. Patients who elect to receive an additional 6 months of belatacept treatment will undergo additional immunologic analysis at 1 year after study entry.
Primary Objective: To analyze the effect of switching from CNI to belatacept in patients with evidence of CNI toxicity on the development and maintenance of immune memory in response to both alloantigen and viral antigens commonly encountered after transplant, and to assess the safety and efficacy of conversion to belatacept as maintenance immunosuppression in combination with prednisone and mycophenolate mofetil.
Study Design: Open label, single center clinical trial. Patients with evidence of CNI toxicity will be eligible for switch to belatacept-based regimen within the first three months after transplant. All enrolled subjects will also receive concomitant maintenance immunosuppression with mycophenolate mofetil and corticosteroids.
Duration of Study: 6 months, with option to extend to 12 months of belatacept treatment Number of Subjects: 20 Study Population: Kidney transplant recipients within the first three months of their first transplant with evidence of CNI toxicity.
Test Product, Dose and Mode of Administration, Duration of Treatment: Study patients will receive intravenous belatacept at 5mg/kg every two weeks at day 1 and weeks 2, 4, 6, and 8, and then monthly at months 3, 4, and 5. At month 6 patients may elect to continue for an additional six month period of belatacept administration. Peripheral blood mononuclear cells (PBMCs) and sera for antibody testing will be collected at time of study entry and at 4, 8, 12, and 24 weeks after belatacept start, frozen and banked at our center, and analyzed in batch fashion for development of humoral and cell mediated immunity. Patients who elect to receive an additional 6 months of belatacept treatment will undergo additional immunologic analysis at 1 year after study entry.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: