xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975450</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00005929</org_study_id>
      <secondary_id>U01AI138909</secondary_id>
      <nct_id>NCT05975450</nct_id>
    </id_info>
    <brief_title>Subcutaneous Abatacept in Renal Transplant Recipients</brief_title>
    <acronym>RTB-016</acronym>
    <official_title>Early Substitution of Subcutaneous Abatacept for Belatacept as Costimulation Blockade to Minimize Calcineurin Inhibitors (CNI) Exposure After Kidney Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Idelberto Badell</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        After a kidney transplant, patients take drugs called anti-rejection drugs&#xD;
        (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is&#xD;
        not possible to have a successful transplant without these drugs. These drugs make it&#xD;
        possible for a person who receives the transplant to accept the &quot;foreign&quot; kidney. Most&#xD;
        patients who get a transplant need to take anti-rejection medications for the rest of their&#xD;
        lives, or for as long as the kidney continues to work.&#xD;
  &#xD;
        Researchers are looking to learn whether abatacept is as good as belatacept in preventing&#xD;
        rejection, whether there are other benefits or harms associated with abatacept treatment, and&#xD;
        possibly allows greater flexibility on patient's travel and time since abatacept is&#xD;
        self-administered at home.&#xD;
  &#xD;
        This study is being done to answer these questions:&#xD;
  &#xD;
        Are weekly abatacept injections under the skin a safe and effective substitute for monthly&#xD;
        belatacept intravenous (IV) infusions? and How well does the kidney function after switching&#xD;
        from belatacept to abatacept?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase I, open-label, prospective, single-arm single-center study to evaluate the&#xD;
        feasibility, effectiveness, and safety of a regimen substituting subcutaneous abatacept early&#xD;
        post-transplant in place of intravenous belatacept as an immunosuppressant in first-time&#xD;
        renal transplant recipients.&#xD;
  &#xD;
        There is a single arm in this study; the Investigational (abatacept) group. Participants will&#xD;
        be assigned to a treatment regimen between 2 and 5 months after transplantation. The study&#xD;
        drug will be administered until month 12 post-transplant; at that point, all participants&#xD;
        will be transitioned to a physician-directed immunosuppressive regimen post-study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The proportion of subjects who tolerate subcutaneous injections and are compliant with self-administration</measure>
      <time_frame>Throughout the study intervention (up to 12 months)</time_frame>
      <description>Measured by abatacept administration logs and autoinjector accountability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The proportion 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.</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The cumulative incidence of serious adverse events</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>Assessments for the development of serious adverse events will be completed at each study visit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of serious infection of special interest</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>Any infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of patients with cytomegalovirus (CMV) viremia stratified by the magnitude</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>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 protocolCMV viremia stratified by count ≥35 but &lt;10,000 or ≥10, 000</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of patients with BK viremia stratified by the magnitude</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>Undetected, &gt;0 but &lt; 1,000, ≥ 1,000 but &lt;10,000 or ≥ 10,000 - 100,000, ≥100,000 or stratified by log, which is reported as a result.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of any malignancy</measure>
      <time_frame>Throughout the study intervention up to 12 months post transplant</time_frame>
      <description>Incidence of any malignancy including Post-Transplant Lymphoproliferative Disorder (PTLD)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of subjects experiencing the composite outcome of death or allograft failure</measure>
      <time_frame>Up to 12 months post transplant</time_frame>
      <description>Death and/or allograft failure at or before 12 months after transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>Incidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects treated for rejection</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>The number of subjects 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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects treated for acute rejection due to clinical suspicion rather than BP-aTCMR or BP-aABMR within 12 months of transplantation.</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with biopsy-proven active antibody-mediated rejection (BP-aABMR)</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with changes in allograft biopsies for the 5 categories of aTCMR specified in the Banff schema</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to changes in allograft biopsies for the 5 categories of aTCMR specified in the Banff schema</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>Calculations will be made from the start of the time abatacept is started up to 12 months. 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects who develop de-novo donor specific antibody (DSA)</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>Proportion of subjects who develop de-novo DSA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in estimated GFR (eGFR)</measure>
      <time_frame>Baseline and 12 months post transplantation</time_frame>
      <description>The difference in eGFR will be calculated using a monthly repeated measures model from the time abatacept is started and 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days to events [TCMR, ABMR, de-novo specific antibodies (DSA) formation, graft loss].</measure>
      <time_frame>Up to 12 months post transplantation</time_frame>
      <description>All events will be documented and calculations will be made from the start of the time abatacept is started up to 12 months.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Kidney Transplant Recipient</condition>
    <arm_group>
      <arm_group_label>Abatacept</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Abatacept 125Mg/Ml Syringe</intervention_name>
      <description>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:&#xD;
  Costimulation blockade:&#xD;
  - Abatacept 125 mg subcutaneous weekly</description>
      <arm_group_label>Abatacept</arm_group_label>
      <other_name>Orencia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must be able to understand and provide informed consent.&#xD;
  &#xD;
            -  Male or Female, 18-70 years of age at the time of enrollment (all races and&#xD;
               ethnicities)&#xD;
  &#xD;
            -  Negative crossmatch (virtual or physical) at the time of transplant&#xD;
  &#xD;
            -  No less than 8 weeks, no more than 20 weeks post-transplant at enrollment&#xD;
  &#xD;
            -  A first-time renal transplant who has been treated with belatacept from the time of&#xD;
               transplant, receiving tacrolimus (target trough 3-5 ng/ml), mycophenolate mofetil (or&#xD;
               mycophenolic acid or azathioprine), prednisone (also see exclusion criteria).&#xD;
  &#xD;
            -  eGFR ≥ 40ml/min/m2 [using 2021 the Chronic Kidney Disease Epidemiology Collaboration&#xD;
               (CKD-EPI) equation].&#xD;
  &#xD;
            -  Must have prior documented evidence of Epstein-Barr virus (EBV) seropositivity.&#xD;
  &#xD;
            -  Female study participants of childbearing potential must have a negative pregnancy&#xD;
               test prior to enrollment.&#xD;
  &#xD;
            -  Agreement to use contraception that is more than 80% effective.&#xD;
  &#xD;
            -  Vaccines are up to date as per the Division of Allergy, Immunology, and&#xD;
               Transplantation (DAIT) guidance for patients in transplant trials.&#xD;
  &#xD;
            -  Study participants must have a negative purified protein derivative (PPD) or negative&#xD;
               testing for tuberculosis using an approved Interferon Gamma Release Assay (IGRA) blood&#xD;
               test, such as QuantiFERON®-Gold tuberculosis (TB) or T-SPOT®-TB assay. PPD or IGRA&#xD;
               testing must be documented to have been performed within the 52 weeks before&#xD;
               enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability or unwillingness of a study participant to give written informed consent or&#xD;
               comply with the study protocol.&#xD;
  &#xD;
            -  Recipient of previous organ transplant of any type.&#xD;
  &#xD;
            -  Multi-organ transplant.&#xD;
  &#xD;
            -  Calculated Panel Reactive Antibody (cPRA) &gt;80 at the time of enrollment.&#xD;
  &#xD;
            -  History of any episode of biopsy-proven Banff rejection (including borderline&#xD;
               rejection or any grade of acute TCMR) prior to enrollment.&#xD;
  &#xD;
            -  History of any malignancy including lymphoma within 5 years of enrollment. Study&#xD;
               participants with curatively treated non-melanomatous skin cancer or curatively&#xD;
               treated cervical carcinoma in situ may be enrolled.&#xD;
  &#xD;
            -  Any past or current issue which in the opinion of the investigator may pose additional&#xD;
               risks to the participant in the study, may interfere with the study participant's&#xD;
               ability to comply with the study requirements, or may impact the quality or&#xD;
               interpretation of the data obtained from the study.&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV): individuals known to be HIV positive.&#xD;
  &#xD;
            -  Hepatitis C virus (HCV): any study participant who receives a kidney from a&#xD;
               seropositive or HCV RNA PCR-positive donor is ineligible. Any study participant who&#xD;
               was HCV RNA PCR positive at transplant is ineligible. Any study participant with a&#xD;
               history of HCV seropositivity or HCV infection who has not met the criteria for&#xD;
               sustained spontaneous clearance or sustained viral response to therapy is ineligible.&#xD;
  &#xD;
            -  Hepatitis B virus (HBV): Individuals with any of the following are NOT eligible:&#xD;
  &#xD;
                 -  Recipient or donor positive for hepatitis B surface antigen (HBsAg)&#xD;
  &#xD;
                 -  Recipient or donor positive for antibodies to hepatitis B core antigen (anti-HBc)&#xD;
  &#xD;
                 -  Recipient or donor is known to have had a positive HBV DNA PCR&#xD;
  &#xD;
            -  Evidence of CMV viremia or clinical CMV infection at any time after transplant.&#xD;
  &#xD;
            -  Kidney recipients who were CMV seronegative who received an organ from a CMV&#xD;
               seropositive donor.&#xD;
  &#xD;
            -  BK viremia of greater than 4.3 DNA log copies/ml (greater than 20,000 copies/ml) at&#xD;
               any time post-transplant.&#xD;
  &#xD;
            -  Active uncontrolled infection within 1 month of enrollment.&#xD;
  &#xD;
            -  Clinically significant proteinuria (urinary protein/Cr ratio &gt;1.0).&#xD;
  &#xD;
            -  Receiving belatacept at a dose other than 5 mg/kg body weight.&#xD;
  &#xD;
            -  Receiving mycophenolate mofetil at a dose of less than 1000 mg daily (or mycophenolic&#xD;
               acid or azathioprine equivalent).&#xD;
  &#xD;
            -  Receiving prednisone at a dose greater than 5 mg daily.&#xD;
  &#xD;
            -  Presence of donor-specific antibody by Luminex single antigen bead assay.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Idelberto R Badell, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Idelberto R Badell, MD</last_name>
      <phone>404-712-6562</phone>
      <email>ibadell@emory.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Emory Clinic</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Idelberto R Badell, MD</last_name>
        <phone>404-712-6562</phone>
        <email>ibadell@emory.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Emory Hospital</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Idelberto R Badell, MD</last_name>
        <phone>404-712-6562</phone>
        <email>ibadell@emory.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Idelberto Badell</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Renal Transplant</keyword>
    <keyword>abatacept</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abatacept</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975450
  org study id: STUDY00005929
  secondary id: U01AI138909
  nct id: NCT05975450
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The proportion of subjects who tolerate subcutaneous injections and are compliant with self-administration
  time frame: Throughout the study intervention (up to 12 months)
  description: Measured by abatacept administration logs and autoinjector accountability.
  measure: The proportion 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.
  time frame: Throughout the study intervention up to 12 months post transplant
  description: 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.
  measure: The cumulative incidence of serious adverse events
  time frame: Throughout the study intervention up to 12 months post transplant
  description: Assessments for the development of serious adverse events will be completed at each study visit.
  measure: Incidence of serious infection of special interest
  time frame: Throughout the study intervention up to 12 months post transplant
  description: Any infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days)
  measure: Incidence of patients with cytomegalovirus (CMV) viremia stratified by the magnitude
  time frame: Throughout the study intervention up to 12 months post transplant
  description: 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 protocolCMV viremia stratified by count ≥35 but <10,000 or ≥10, 000
  measure: Incidence of patients with BK viremia stratified by the magnitude
  time frame: Throughout the study intervention up to 12 months post transplant
  description: 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.
  measure: Incidence of any malignancy
  time frame: Throughout the study intervention up to 12 months post transplant
  description: Incidence of any malignancy including Post-Transplant Lymphoproliferative Disorder (PTLD)
  measure: The proportion of subjects experiencing the composite outcome of death or allograft failure
  time frame: Up to 12 months post transplant
  description: Death and/or allograft failure at or before 12 months after transplantation
  measure: Number of subjects with biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)
  time frame: Up to 12 months post transplantation
  description: Incidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)
  measure: Number of subjects treated for rejection
  time frame: Up to 12 months post transplantation
  description: The number of subjects 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
  measure: Number of subjects treated for acute rejection due to clinical suspicion rather than BP-aTCMR or BP-aABMR within 12 months of transplantation.
  time frame: Up to 12 months post transplantation
  description: 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.
  measure: Number of subjects with biopsy-proven active antibody-mediated rejection (BP-aABMR)
  time frame: Up to 12 months post transplantation
  description: 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.
  measure: Number of subjects with changes in allograft biopsies for the 5 categories of aTCMR specified in the Banff schema
  time frame: Up to 12 months post transplantation
  description: 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.
  measure: Time to changes in allograft biopsies for the 5 categories of aTCMR specified in the Banff schema
  time frame: Up to 12 months post transplantation
  description: Calculations will be made from the start of the time abatacept is started up to 12 months. 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.
  measure: Number of subjects who develop de-novo donor specific antibody (DSA)
  time frame: Up to 12 months post transplantation
  description: Proportion of subjects who develop de-novo DSA
  measure: Change in estimated GFR (eGFR)
  time frame: Baseline and 12 months post transplantation
  description: The difference in eGFR will be calculated using a monthly repeated measures model from the time abatacept is started and 12 months.
  measure: Number of days to events [TCMR, ABMR, de-novo specific antibodies (DSA) formation, graft loss].
  time frame: Up to 12 months post transplantation
  description: All events will be documented and calculations will be made from the start of the time abatacept is started up to 12 months.
  arm group label: Abatacept
  arm group type: Experimental
  description: 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.
  intervention type: Drug
  intervention name: Abatacept 125Mg/Ml Syringe
  description: 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
  arm group label: Abatacept
  other name: Orencia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Idelberto R Badell, MD
  role: Principal Investigator
  affiliation: Emory University
  last name: Idelberto R Badell, MD
  phone: 404-712-6562
  email: ibadell@emory.edu
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Emory University
  investigator full name: Idelberto Badell
  investigator title: Assistant Professor
  mesh term: Abatacept
  sharing ipd: No