Abatacept Conversion in Kidney Transplantation

October 9, 2025 updated by: Idelberto Badell, Emory University

Late Abatacept Conversion in Kidney Transplant Recipients Receiving Belatacept: a Prospective, Randomized Controlled Non-inferiority Trial. IM101-884

This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function.The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function. Research subjects will be recruited from those who were initiated on belatacept at the time of their kidney transplant and have been stable on belatacept therapy for at least 2 years post-transplant and off CNI therapy for at least 6 months.

A total of 86 subjects will be randomized in equal numbers, 43 patients in each arm. Enrollment of all 86 patients is expected to be completed within 1.5 years. All patients will be actively followed in the study for 24 months following randomization. The patient participation is projected to last a total of 3.5 years with data analysis to follow.

The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital (EUH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

  1. Adult (age ≥18 years currently)

  2. First-time renal transplant recipients of either living donor or deceased donor

    1. Treatment with belatacept from the time of transplant
    2. At least 2 years post-transplant and off CNI therapy for at least 6 months

  3. Patients at low immunologic risk

    1. First time transplant
    2. HLA antibody screen with PRA < 80% against class I and class II antigens
    3. Negative crossmatch (actual or virtual)
    4. No donor specific anti-HLA antibody (DSA)
    5. No more than one episode of rejection (Banff grade 1A or greater)
    6. No episodes of rejection (borderline or greater) within the last 6 months prior to study participation
    7. No rejection of Banff grade IIB or greater
  4. Immunosuppression consisting of belatacept (5mg/kg q 1M), mycophenolate mofetil (at least 1000 mg daily), or equivalent mycophenolic acid (720 mg daily) or azathioprine (1- 2 mg/kg daily) dose, and prednisone 5 mg daily.
  5. Confirmed Tb screening at the time of transplantation

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

  1. Repeat renal transplant, or multi-organ transplant recipient
  2. History of more than one episode of biopsy-proven acute rejection (Banff grade 1A or greater), or of any episode of rejection of Banff 97 grade IIB or greater, or any rejection (borderline or greater) within the last 6 months
  3. Pregnancy (women of childbearing potential must use adequate contraception during study)
  4. GFR less than 35
  5. Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization
  6. Recent history of clinically significant proteinuria (urinary protein/Cr ratio >1.0)
  7. Receiving belatacept at a dose other than 5 mg/kg body weight
  8. Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent).
  9. Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment
  10. Not currently receiving maintenance immunosuppression with prednisone
  11. Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
  12. Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization.
  13. BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization
  14. Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
  15. Known HIV-positivity (testing not required)
  16. Presence of donor specific antibody by Luminex single antigen bead assay, or antibody screen (% PRA) above 80%.
  17. History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
  18. History of medical noncompliance
  19. Untreated latent Tb (as determined from prior Tb screening at the time of transplantation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Belatacept group (Control Group)

Participants will receive the following:

  • Belatacept: 5 mg/kg i.v. monthly
  • Blood draws for PD studies at baseline/Month 0 and Month 6 fora total of two timepoints.
  • HLA labs at 6, 12 and 24 months
  • Basic chemistry panel (CP Basic) every 3 months per clinical protocol for efficacy analysis
  • Hemoglobin A1c at Screening visit
  • Urine pregnancy test via test kit for WOCP at Screening visit
  • BK and CMV testing at 6, 12, and 24 months
Drug: Belatacept
Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg monthly
Other Names:
  • Nulojix
Experimental: Abatacept Group (Conversion Group)

Participants will receive the following:

  • Abatacept 125 mg s.c. weekly
  • Safety labs every 2 weeks (months 0-3) then monthly (months 4-12)
  • Blood draws forPK atMonth 6, Month 12, and two random time points in between Month 6 and Month 12 for a total of four time points.
  • Blood draws for PD studies at baseline/Month0 and Month 6 fora total of two timepoints.
  • HLA labs at 6, 12 and 24 months
  • Basic chemistry panel (CP Basic) at each study visit per clinical protocol for efficacy analysis
  • Hemoglobin A1c at Screening visit
  • Urine pregnancy test via test kit for WOCP at screening
  • BK and CMV testing at 6, 12, and 24 months
Drug: Abatacept
Abatacept is an immunosuppressive medication and will be given SQ at a dose of 125 mg s.c. weekly
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in mean estimated GFR (eGFR) between randomization and 12 months post baseline
Time Frame: Baseline, 12 months post baseline
Difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.
Baseline, 12 months post baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in eGFR between abatacept and belatacept groups at 24 months
Time Frame: Monthly until 24 months post baseline
The treatment difference in eGFR between abatacept and belatacept groups at 24 months, using a monthly repeated measures model and a pre-specified acceptable difference, or non-inferiority margin of 5 ml/min/1.73m2.
Monthly until 24 months post baseline
Number of subjects with biopsy proven acute rejection: Acute Cellular Rejection (ACR)
Time Frame: 12 months post baseline, 24 months post baseline
Incidence and severity of acute cellular rejection (ACR)
12 months post baseline, 24 months post baseline
Number of subjects with biopsy proven acute rejection: Antibody Mediated Rejection (AMR)
Time Frame: 12 months post baseline, 24 months post baseline
Incidence and severity of antibody mediated rejection (AMR) analyses
12 months post baseline, 24 months post baseline
Number of participants with kidney transplant biopsies post baseline
Time Frame: 12 months post baseline, 24 months post baseline
Number of participants with kidney transplant biopsies post baseline
12 months post baseline, 24 months post baseline
Proportion of subjects treated for ACR/AMR due to clinical suspicion
Time Frame: 12 months post baseline, 24 months post baseline
Proportion of subjects treated for ACR/AMR due to clinical suspicion
12 months post baseline, 24 months post baseline
Number of subjects with de novo anti-donor human leukocyte antigen (HLA) antibodies
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of de novo anti-donor human leukocyte antigen (HLA) antibodies
12 months post baseline, 24 months post baseline
First occurrence of graft loss or death post baseline
Time Frame: 12 months post baseline, 24 months post baseline
First occurrence of graft loss or death at 6, 12 and 24 months post baseline
12 months post baseline, 24 months post baseline
Number of deaths at 6, 12 and 24 months post baseline
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of death with graft function at 6, 12 and 24 months post baseline
12 months post baseline, 24 months post baseline
Incidence of death-censored graft loss post baseline
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of death-censored graft loss at 12 and 24 months
12 months post baseline, 24 months post baseline
Compliance with patient-administered subcutaneous abatacept
Time Frame: 12 months post baseline, 24 months post baseline
Compliance with patient-administered subcutaneous abatacept
12 months post baseline, 24 months post baseline
Incidence of adverse events
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of adverse events
12 months post baseline, 24 months post baseline
Incidence of serious adverse events
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of serious adverse events
12 months post baseline, 24 months post baseline
Incidence of events of special interest
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of events of special interest, including CMV viremia, BKV viremia, and serious infections
12 months post baseline, 24 months post baseline
Incidence of any malignancy
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of any malignancy including PTLD
12 months post baseline, 24 months post baseline
Incidence of subcutaneous injection site complications
Time Frame: 12 months post baseline, 24 months post baseline
Incidence of subcutaneous injection site complications
12 months post baseline, 24 months post baseline
Proportion of subjects who develop de-novo, anti-HLA donor specific antibody
Time Frame: 12 months post baseline, 24 months post baseline
Proportion of subjects who develop de-novo, anti-HLA donor specific antibody
12 months post baseline, 24 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Idelberto R Badell, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article will be shared, after de identification (text, tables, figures, and appendices) to Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, for individual participant data meta-analysis.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University&amp;amp;amp;amp;#39;s data warehouse but without investigator support other than deposited metadata.

Individual participant data that underlie the results reported in this article will be shared, after de identification (text, tables, figures, and appendices) to Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, for individual participant data meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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