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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI138909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental | Participants on a qualifying belatacept regimen will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept 125Mg/Ml Syringe | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Compliant With Self-administration | Compliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability. | 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. | 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. | 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. | 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. | Up to 12 months post-transplantation, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure | Death and/or allograft failure at or before 12 months after transplantation | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Inability or unwillingness of a study participant to give written informed consent or comply with the study protocol.
Recipient of previous organ transplant of any type.
Multi-organ transplant.
Calculated Panel Reactive Antibody (cPRA) >80 at the time of enrollment.
History of any episode of biopsy-proven Banff rejection (including borderline rejection or any grade of acute TCMR) before enrollment.
History of any malignancy including lymphoma within 5 years of enrollment. Study participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled.
Any past or current issue which in the opinion of the investigator may pose additional risks to the participant in the study, may interfere with the study participant's ability to comply with the study requirements, or may impact the quality or interpretation of the data obtained from the study.
Human immunodeficiency virus (HIV): individuals known to be HIV positive.
Hepatitis C virus (HCV): any study participant who receives a kidney from a seropositive or HCV RNA PCR-positive donor is ineligible. Any study participant who was HCV RNA PCR positive at transplant is ineligible. Any study participant with a history of HCV seropositivity or HCV infection who has not met the criteria for sustained spontaneous clearance or sustained viral response to therapy is ineligible.
Hepatitis B virus (HBV): Individuals with any of the following are NOT eligible:
Evidence of CMV viremia or clinical CMV infection at any time after transplant.
Kidney recipients who were CMV seronegative who received an organ from a CMV seropositive donor.
BK viremia of greater than 4.3 DNA log copies/ml (greater than 20,000 copies/ml) at any time post-transplant.
Active uncontrolled infection within 1 month of enrollment.
Clinically significant proteinuria (urinary protein/Cr ratio >1.0).
Receiving belatacept at a dose other than 5 mg/kg body weight.
Receiving mycophenolate mofetil at a dose of less than 1000 mg daily (or mycophenolic acid or azathioprine equivalent).
Receiving prednisone at a dose greater than 5 mg daily.
Presence of donor-specific antibody by Luminex single antigen bead assay.
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| Name | Affiliation | Role |
|---|---|---|
| Idelberto R Badell, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| Emory Hospital |
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Participants were recruited from Emory Healthcare of Atlanta in Atlanta, Georgia, USA. Participant enrollment began August 2, 2023, and all follow-up was complete by February 14, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | 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. Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | 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. Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Are Compliant With Self-administration | Compliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abatacept | 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. Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Rejection | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Idelberto R Badell, MD | Emory University | 404-712-6562 | ibadell@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2023 | Jan 23, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2024 | Mar 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D013594 | Syringes |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
|
| 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. | 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) | Up to 12 months post-transplantation, an average of 8 months |
Incidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR) |
| 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 | 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. | 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. | 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. | 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. | 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 | 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 | 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. | Up to 12 months post-transplantation, an average of 8 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
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| Primary | Number of Participants Who Develop Any Malignancy | Incidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD) | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
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|
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| Secondary | Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure | Death and/or allograft failure at or before 12 months after transplantation | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
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|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
|
|
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| Secondary | 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. | Only one participant developed changes in their allograft biopsies. | Posted | Number | days | Up to 12 months post-transplantation, an average of 8 months |
|
|
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| Secondary | Number of Participants Who Develop De-novo Donor Specific Antibody (DSA) | Number of participants who develop de-novo DSA | Posted | Count of Participants | Participants | Up to 12 months post-transplantation, an average of 8 months |
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|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | The eGFR will be calculated at the time abatacept is started and 12 months post-transplant | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline and 12 months post-transplantation |
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| Secondary | 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. | Only one participant developed changes in their allograft biopsies. | Posted | Number | days to acute rejection | Up to 12 months post-transplantation, an average of 8 months |
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|
| 0 |
| 14 |
| 1 |
| 14 |
| 1 |
| 14 |
| Hematospermia | Reproductive system and breast disorders | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Increased creatinine | Investigations | Non-systematic Assessment |
|
| Possible Class II Donor-Specific Antibodies (DSA) | Immune system disorders | Non-systematic Assessment |
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| Acute kidney injury (AKI) | Renal and urinary disorders | Non-systematic Assessment |
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| Low white blood cell (WBC) count | Investigations | Non-systematic Assessment |
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| Viremia | Infections and infestations | Non-systematic Assessment |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D004864 | Equipment and Supplies |
| ≥ 10,000 - 100,000 |
|
| 100,000 ≥ 100,000 |
|