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Renal Transplant RecipientPhase 2NCT04955366

Abatacept Conversion in Kidney Transplantation

A Phase 2 study testing Belatacept and Abatacept in people with Renal Transplant Recipient, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Transplant Recipient
What is being tested?
Belatacept and Abatacept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
22 Sep 2021to 10 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who meet all of the following criteria are eligible for enrollment as study participants:
  • Adult (age ≥18 years currently)
  • First-time renal transplant recipients of either living donor or deceased donor
  • Treatment with belatacept from the time of transplant
  • At least 2 years post-transplant and off CNI therapy for at least 6 months
  • Patients at low immunologic risk
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  • First time transplant
  • HLA antibody screen with PRA < 80% against class I and class II antigens
  • Negative crossmatch (actual or virtual)
  • No donor specific anti-HLA antibody (DSA)
  • No more than one episode of rejection (Banff grade 1A or greater)
  • No episodes of rejection (borderline or greater) within the last 6 months prior to study participation
  • No rejection of Banff grade IIB or greater
  • 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.
  • Confirmed Tb screening at the time of transplantation

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants:
  • Repeat renal transplant, or multi-organ transplant recipient
  • 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
  • Pregnancy (women of childbearing potential must use adequate contraception during study)
  • GFR less than 35
  • Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization
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  • Recent history of 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 po QD (or mycophenolic acid or azathioprine equivalent).
  • Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment
  • Not currently receiving maintenance immunosuppression with prednisone
  • Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
  • Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization.
  • BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization
  • Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
  • Known HIV-positivity (testing not required)
  • Presence of donor specific antibody by Luminex single antigen bead assay, or antibody screen (% PRA) above 80%.
  • History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
  • History of medical noncompliance
  • Untreated latent Tb (as determined from prior Tb screening at the time of transplantation)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital (EUH)

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Belatacept, Abatacept
Keywords
Renal transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelataceptDrug

    Also called Nulojix

    Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg monthly

  • AbataceptDrug

    Also called Orencia

    Abatacept is an immunosuppressive medication and will be given SQ at a dose of 125 mg s.c. weekly

Study groups in NCT04955366
Study groupRoleWhat they receive
Belatacept group (Control Group)Active comparatorParticipants 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
Receives: Drug: Belatacept
Abatacept Group (Conversion Group)ExperimentalParticipants 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
Receives: Drug: Abatacept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean estimated GFR (eGFR) between randomization and 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.

    Measured: Baseline, 12 months post baseline

Secondary outcomes (16)

  1. Change in eGFR between abatacept and belatacept groups at 24 months

    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.

    Measured: Monthly until 24 months post baseline

  2. Number of subjects with biopsy proven acute rejection: Acute Cellular Rejection (ACR)

    Incidence and severity of acute cellular rejection (ACR)

    Measured: 12 months post baseline, 24 months post baseline

  3. Number of subjects with biopsy proven acute rejection: Antibody Mediated Rejection (AMR)

    Incidence and severity of antibody mediated rejection (AMR) analyses

    Measured: 12 months post baseline, 24 months post baseline

  4. Number of participants with kidney transplant biopsies post baseline

    Number of participants with kidney transplant biopsies post baseline

    Measured: 12 months post baseline, 24 months post baseline

  5. Proportion of subjects treated for ACR/AMR due to clinical suspicion

    Proportion of subjects treated for ACR/AMR due to clinical suspicion

    Measured: 12 months post baseline, 24 months post baseline

  6. Number of subjects with de novo anti-donor human leukocyte antigen (HLA) antibodies

    Incidence of de novo anti-donor human leukocyte antigen (HLA) antibodies

    Measured: 12 months post baseline, 24 months post baseline

  7. First occurrence of graft loss or death post baseline

    First occurrence of graft loss or death at 6, 12 and 24 months post baseline

    Measured: 12 months post baseline, 24 months post baseline

  8. Number of deaths at 6, 12 and 24 months post baseline

    Incidence of death with graft function at 6, 12 and 24 months post baseline

    Measured: 12 months post baseline, 24 months post baseline

  9. Incidence of death-censored graft loss post baseline

    Incidence of death-censored graft loss at 12 and 24 months

    Measured: 12 months post baseline, 24 months post baseline

  10. Compliance with patient-administered subcutaneous abatacept

    Compliance with patient-administered subcutaneous abatacept

    Measured: 12 months post baseline, 24 months post baseline

  11. Incidence of adverse events

    Incidence of adverse events

    Measured: 12 months post baseline, 24 months post baseline

  12. Incidence of serious adverse events

    Incidence of serious adverse events

    Measured: 12 months post baseline, 24 months post baseline

  13. Incidence of events of special interest

    Incidence of events of special interest, including CMV viremia, BKV viremia, and serious infections

    Measured: 12 months post baseline, 24 months post baseline

  14. Incidence of any malignancy

    Incidence of any malignancy including PTLD

    Measured: 12 months post baseline, 24 months post baseline

  15. Incidence of subcutaneous injection site complications

    Incidence of subcutaneous injection site complications

    Measured: 12 months post baseline, 24 months post baseline

  16. Proportion of subjects who develop de-novo, anti-HLA donor specific antibody

    Proportion of subjects who develop de-novo, anti-HLA donor specific antibody

    Measured: 12 months post baseline, 24 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start22 Sep 2021
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized controlled non-inferiority trial
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04955366
Sponsor's protocol ID
STUDY00001855
Status last verified
Sep 2026
First submitted
28 Jun 2021
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belatacept and Abatacept in people with Renal Transplant Recipient, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean estimated GFR (eGFR) between randomization and 12 months post baseline (time frame: Baseline, 12 months post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04955366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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