After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work. Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home. This study is being done to answer these questions: Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?
This is a Phase I, open-label, prospective, single-arm single-center study to evaluate the feasibility, effectiveness, and safety of a regimen substituting subcutaneous abatacept early post-transplant in place of intravenous belatacept as an immunosuppressant in first-time renal transplant recipients. There is a single arm in this study; the Investigational (abatacept) group. Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants on a qualifying belatacept regimen (with low-dose tacrolimus, mycophenylate mofetil (MMF), and prednisone) will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant: Costimulation blockade: \- Abatacept 125 mg subcutaneous weekly
Emory Clinic
Atlanta, Georgia, United States
Emory Hospital
Atlanta, Georgia, United States
Number of Participants Who Are Compliant With Self-administration
Compliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated Rejection (aTCMR) or Antibody-mediated Rejection (ABMR) as Defined by Banff Criteria at or Before 12 Months After Transplantation.
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Presenting Serious Adverse Events
Assessments of serious adverse events will be completed at each study visit from the time abatacept starts through 12 months post-transplant.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Serious Infections
Any serious infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days, will be documented.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude
All subjects will be monitored for CMV infection by quantitative polymerase chain reaction (PCR) in the blood per the Emory Transplant Center standard of care protocol, CMV viremia stratified by count ≥35 but \<10,000 or ≥ 10,000.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Patients With BK Viremia Stratified by the Magnitude
Undetected, \>0 but \< 1,000, ≥ 1,000 but \<10,000, or ≥ 10,000 - 100,000, ≥100,000 or stratified by log, which is reported as a result.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Develop Any Malignancy
Incidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD)
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure
Death and/or allograft failure at or before 12 months after transplantation
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Acute T-cell Mediated Cellular Rejection (BP-aTCMR)
Incidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Rejection
The number of participants treated for rejection with any of the following: i) corticosteroids within 12 months, ii) T-cell depleting therapy within 12 months, iii) any other treatment for rejection within 12 months of transplantation
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Treated for Acute Rejection Due to Clinical Suspicion Rather Than BP-aTCMR or BP-aABMR Within 12 Months of Transplantation.
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Biopsy-proven Active Antibody-mediated Rejection (BP-aABMR)
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants With Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
For-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
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Time frame: Up to 12 months post-transplantation, an average of 8 months
Time to Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
Calculations will be made from the start of abatacept through to 12 months post-transplant. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Time frame: Up to 12 months post-transplantation, an average of 8 months
Number of Participants Who Develop De-novo Donor Specific Antibody (DSA)
Number of participants who develop de-novo DSA
Time frame: Up to 12 months post-transplantation, an average of 8 months
Estimated Glomerular Filtration Rate (eGFR)
The eGFR will be calculated at the time abatacept is started and 12 months post-transplant
Time frame: Baseline and 12 months post-transplantation
Number of Days to Events [TCMR, ABMR, De-novo Specific Antibodies (DSA) Formation, Graft Loss].
All events will be documented, and calculations will be made from the start of abatacept through 12 months post-transplant.
Time frame: Up to 12 months post-transplantation, an average of 8 months