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Kidney TransplantPhase 2NCT05917522

Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation

A Phase 2 study testing Abatacept in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Kidney Transplant
What is being tested?
Abatacept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
15 sitesUnited States
Study dates
7 Dec 2023to Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Observational Study:
  • Subject must be able to understand and provide informed consent
  • Received (within 14 days) or candidate for an ABO-compatible kidney transplant, including A2 to B
  • Panel Reactive Antibody <=60% as determined by local site
  • Virtual cross-match negative as determined by local site or Donor Specific Antibody (DSA) negative by central lab within 14 days post-transplant
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
Show all 25Show fewer
  • All subjects with reproductive potential must agree to use highly effective contraception for the duration of the study (http://www.fda.gov/birthcontrol)
  • Hepatitis C Virus Ab positive subjects with negative Hepatitis C Virus polymerase chain reaction (HCV PCR) are eligible if they have spontaneously cleared infection or are in sustained virologic remission
  • Vaccines up to date as per Division of Allergy, Immunology, and Transplantation (DAIT) guidance for patients in transplant trials (Refer to Manual of Procedures).
  • Triple Immunosuppression - Calcineurin Inhibitor/Mycophenolic Acid/Steroid (CNI/MPA/steroid)
  • CNI (Tacrolimus (TAC), target trough [C0] level: 0-3 mo, 8-12 ng/mL; 4-6 mo, 6-10 ng/mL; >6 mo, 5-8 ng/mL])
  • MPA [target dose: mycophenolate mofetil >=500 mg bid or mycophenolate sodium >=360 mg bid]); and
  • Glucocorticoid, with a minimum dose equivalent to 5mg of prednisone per day
  • Nested Randomized Control Trial (RCT):
  • Subject must be able to understand and provide informed consent
  • A 6-month protocol biopsy free of Biopsy Proven Acute Rejection (BPAR)(by Central Pathology Core)
  • Negative 6-month serum test for DSA (by Central HLA Core)
  • eGFRCKD-EPI 30-90 ml/min/1.73m^2 at 6 months
  • Has a verified negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON Gold TB or T-SPOT-TB assay OR has completed treatment for latent tuberculosis and has a negative chest x-ray. PPD or IGRA testing must occur within 52 weeks prior to randomization. These requirements apply as well to prior recipients of Bacille Calmette-Gurin (BCG) vaccination
  • Minimum Mycophenolate mofetil (MPA) dose (MPA 500 mg po bid, or Mycophenolate sodium 360 mg po bid)
  • Minimum Prednisone dose of 5mg per day
  • Hepatitis C Virus Ab positive subjects with negative HCV PCR are eligible if they have spontaneously cleared infection or are in sustained virologic remission
  • Hepatitis C Virus negative recipients of a Hepatitis C Virus positive organ are eligible if they have undergone treatment and are in sustained virologic remission
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
  • All subjects with reproductive potential, must agree to use highly effective contraception the duration of the study-specific methods may be listed, if applicable

Who cannot join

  • Observational Study:
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol including a mandated 6-mo kidney transplant biopsy
  • Non-Kidney Transplant (KTx) (pre-existing or concurrent)
  • Current use of immunomodulatory agents (including but not limited to: Rituximab, anti-Tumor necrosis factor(TNF) Monoclonal antibodies (mAb), or Belatacept, abatacept, Janus kinase inhibitors)
  • Transplant in which the kidney donor is the recipient's Identical twin
  • Epstein-Barr virus (EBV) sero-negative KTx recipient
Show all 31Show fewer
  • Chronic obstructive pulmonary disease (COPD)
  • Untreated Latent Tuberculosis (TB)
  • Human immunodeficiency virus (HIV) infection
  • Active Hepatitis B infection (HBsAg+ or anti-HBcore +)
  • Enrollment in another investigational trial
  • Current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
  • Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
  • Use of investigational drugs within 8 weeks of participation
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
  • Use of Campath(R)
  • Nested Randomized Control Trial (RCT):
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Biopsy Proven Acute Rejection (BPAR) or treated clinically-diagnosed rejection in the 6 months following enrollment in the Observational Study
  • Positive for a Donor Specific Antibody (DSA) 0-6 months post-kidney transplant
  • Acute Banff interstitial (i) score >0 on a 6-month protocol biopsy as determined by core pathology read
  • Presence of recurrent on de novo glomerulonephropathy 0-6 months post-kidney transplant
  • Presence of active infection including BK virus (BKV), Cytomegalovirus (CMV) or EBV viremia by Polymerase chain reaction (PCR) analysis
  • Unable or unwilling to undergo protocol biopsies
  • Not on Tacrolimus/Mycophenolic Acid (MPA)/Pred
  • Unable to administer therapy s.c.
  • Thrombocytopenia (<50,000/mm^3)
  • Pregnant, or unwilling to practice highly effective birth control
  • Use of immunomodulatory agents (including but not limited to Rituximab, anti-TNF mAb, or Belatacept, abatacept, Janus kinase inhibitors) * since enrollment, other than cytolytic agents (i.e., Thymoglobulin(R)or Campath(R) or Basiliximab(R) used for induction therapy at the time of transplant
  • Use of investigational drugs since transplant
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

15 sites in 1 country

United States15 sites, 15 recruiting

  • Johns Hopkins Hospital:Transplantation

    Baltimore, Maryland, 21287

    Tabindah Sayed, 410-955-5045, tsayed1@jh.edu

    Daniel Brennan, M.D.

    Recruiting

  • University of Alabama School of Medicine: Transplantation

    Birmingham, Alabama, 35233

    Amanda O'Hara, 205-934-4011, acharbin@uabmc.edu

    Gaurav Agarwal, M.D.

    Recruiting

  • Massachusetts General Hospital: Transplantation

    Boston, Massachusetts, 02114

    Olivia Bourgeois, 617-726-5050, obourgeois@mgb.org

    Leonardo Riella, M.D.

    Recruiting

  • University of Virginia Health System: Transplantation

    Charlottesville, Virginia, 22908

    Erin Mitchell, 866-900-0218, em3nt@uvahealth.org

    Alden Doyle, M.D.

    Recruiting

  • Cleveland Clinic Foundation: Transplantation

    Cleveland, Ohio, 44195

    Emilio Poggio, M.D.

    Not yet recruiting

  • Duke University Medical Center: Transplantation

    Durham, North Carolina, 27710

    Jerry Turner, 919-668-2279, jerry.turner@duke.edu

    Debra Sudan, M.D.

    Recruiting

  • Cedars Sinai Medical Center: Transplantation

    Los Angeles, California, 90048

    Tillie Morrisette, 310-423-2780, Tillie.Morrisette@cshs.org

    Jun Shoji, M.D.

    Recruiting

  • Ronald Reagan UCLA Medical Center: Transplantation

    Los Angeles, California, 90095

    Rana Nikbakht, 310-267-2555, RNikbakht@mednet.ucla.edu

    Suphamai Bunnapradist, M.D.

    Recruiting

  • University of Wisconsin School of Medicine and Public Health: Transplantation

    Madison, Wisconsin, 53726

    David Foley, M.D.

    Not yet recruiting

  • Yale University, School of Medicine: Transplantation

    New Haven, Connecticut, 06519

    Cameron Groshek, 203-785-4184, cameron.groshek@yale.edu

    Richard Formica, M.D.

    Recruiting

  • University of Nebraska Medical Center: Transplantation

    Omaha, Nebraska, 68198

    Kathleen Tinley, 402-559-5000, ktinley@unmc.edu

    Eric Langewisch, M.D.

    Recruiting

  • University of Pennsylvania Medical Center: Transplantation

    Philadelphia, Pennsylvania, 19104

    Sankalpa Bannikuppe, 215-662-4643, Sankalpa.Bannikuppe@Pennmedicine.upenn.edu

    Roy Bloom, M.D.

    Recruiting

  • University of Pittsburgh Medical Center: Transplantation

    Pittsburgh, Pennsylvania, 15213

    Beth Elinoff, 412-647-5800, elinbd@upmc.edu

    Chethan Puttarajappa, M.D.

    Recruiting

  • Mayo Clinic Rochester: Transplantation

    Rochester, Minnesota, 55905

    Julie Gecox Hanson, 507-284-2511, Gecox.julie@mayo.edu

    Carrie Schinstock, M.D.

    Recruiting

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

    Gwendolyn Amurao, 314-362-8351, amurao@wustl.edu

    Tarek Alhamad, M.D.

    Recruiting

Other trials in United States

About this study

Official title: Assessment of Biomarker-Guided Calcineurin Inhibitor (CNI) Substitution In Kidney Transplantation (RTB-015)

800 adult first time kidney transplant recipients will be enrolled in the Observational Study and followed to evaluate their Human Leukocyte Antigen (HLA)-DR/DQ molecular mismatch (mMM) score as a risk-stratifying prognostic biomarker. Six months after transplant the study will identify those who meet the eligibility criteria for the Nested Randomized Control Trial (RCT). 300 eligible subjects will be randomized 2:1 to abatacept or Standard of care (SOC) in the randomization and followed for 18 months monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM).

The primary objective of the Observational Study is to test the validity of the HLA-DR/DQ mMM score as a prognostic biomarker for stratification of post-transplant alloimmune risk. Whereas the objective of the Nested RCT is to test whether a superior outcome in kidney function (primary endpoint), as well as secondary endpoints (neurocognitive function, and life participation PROM), will be achieved in patients who are transitioned from Tacrolimus (TAC) to abatacept, while maintaining efficacy (freedom from biopsy proven acute rejection).

Read the detailed description

Observational Study:

Enrolling 800 adult first time kidney transplant recipients. Consent and enrollment will be targeted to occur pre- or post-kidney transplant during the initial hospitalization. All subjects enrolled in the study will be followed observationally to evaluate HLA-DR/DQ molecular mismatched (mMM) as a risk-stratifying prognostic biomarker.

This prospective, multi-center, observational study of 800 kidney transplant recipients at clinically low risk for alloimmune memory (DSA negative pre-kidney transplant) who are initiated on standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA mMM score as a prognostic biomarker for post-kidney transplant outcomes in a real-world cohort. Donor-recipient HLA-DR/DQ mMM score will be determined at enrollment and recipients will be followed over 24 months post- kidney transplant for primary alloimmune events (i.e., T cell Mediated Rejection (TCMR), DSA, and Antibody Mediated Rejection (ABMR) ).

Nested RCT (SOC versus conversion to abatacept):

We will follow subjects in the Observational Study for the initial 6 months to identify those who meet the stringent "immune-quiescent" randomization criteria: absence of biopsy proven acute rejection (BPAR) on a for-cause or 6-month surveillance biopsy; and absence of DSA. In addition, these subjects must have absence of infection (e.g., BKV/CMV), and be on at least MMF ≥500 mg p.o. bid at the time of randomization. From this "immune-quiescent" group those individuals with a low or intermediate HLA-DR/DQ mMM score will be eligible for the Nested RCT.

300 eligible subjects will be randomized 2:1 to abatacept or SOC in the randomization phase (Abatacept arm: 200 vs. SOC arm: 100) to have adequate power for detecting differences between the treatment groups. Subjects enrolled into the trial's screening phase (0-6 months post-transplant) of the Observational Study will identify at least 360 kidney transplant recipients who exhibit immune quiescence and who meet the 6-months post-kidney transplant eligibility criteria for the Nested RCT. These individuals will be re-consented prior to randomization at 6-months post-kidney transplant.

Being tested
Abatacept, Standard of Care at US Transplant Centers
Keywords
Kidney Transplant, Abatacept, HLA-DR/DQ mMM

What participants receive

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

  • AbataceptBiological

    Also called Orencia

    Injection: 125 mg/mL of a clear to slightly opalescent, colorless to pale-yellow solution in a single-dose prefilled ClickJect autoinjector

  • Standard of Care at US Transplant CentersProcedure or surgery

    Control group, remaining on SOC (Tacrolimus/ Mycophenolic Acid (MPA)/ Prednisone (Pred))

Study groups in NCT05917522
Study groupRoleWhat they receive
Observational Study - Full CohortNo intervention800 adults first kidney transplant recipients will be followed observationally to evaluate HLA-DR/DQ molecular mismatch (mMM) as a risk-stratifying prognostic biomarker. Donor-recipient HLA-DR/DQ mMM score will be determined at enrollment and recipients will be followed over 24-months post-kidney transplant for primary alloimmune events (i.e., TCMR, DSA, and ABMR). Standard of care (SOC) therapy will be used to satisfy the FDA requirement to prospectively evaluate the HLA-DR/DQ mMM score as a prognostic biomarker for post-kidney transplant outcomes.
Nested RCT - Treatment Group (Abatacept)ExperimentalEligible subjects will be re-consented and randomized to the investigational (abatacept/Mycophenolate mofetil (MMF)/Pred) Arm. Starting with abatacept at a fixed dose (125 mg s.c. weekly) and eliminate Calcineurin Inhibitor (CNI) over ~3 months using serial Tacrolimus (TAC) C0 level targets to taper the dose. 2200 subjects will be followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.
Receives: Biological: Abatacept
Nested RCT - Control Group (SOC)Active comparatorEligible subjects will be re-consented and randomized to the control group (tacrolimus/Mycophenolate mofetil (MMF)/Pred) . 100 subjects will be and followed for 18 months post-randomization, monitoring for safety and improvement in renal function, neurocognitive function, and a life participation patient reported outcome measure (PROM). Subjects who develop Biopsy Proven Acute Rejection (BPAR) will have concurrent serum/urine/tissue samples collected and stored.
Receives: Procedure: Standard of Care at US Transplant Centers

What is being measured

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

  1. In the Observational Study - The occurrence of any alloimmune event

    including de novo Donor Specific Antibody (DSA), any Biopsy Proven Acute Rejection (BPAR) (Banff borderline or greater, on a for-cause or the 6-month post-transplant protocol biopsy) and censored by non-alloimmune graft failure or death with function or lost-to-follow up.

    Measured: Up to 24 months post-Kidney Transplant

  2. In the Nested Randomized Control Trial (RCT) - Renal function, measured as the difference in eGFRCKD-EPI at 24-months between groups (adjusted for renal function at randomization).

    Measured: At 18 months post-randomization (24 months post-transplant)

Secondary outcomes (3)

  1. In the Observational Study - The occurrence of any alloimmune event

    Each component of the primary outcome, de novo Class II Donor Specific Antibody (DSA), and renal function (eGFRCKD-EPI)

    Measured: At 24 months post-Kidney Transplant (post-kidney transplant)

  2. In the Nested Randomized Control Trial (RCT) - Composite neurocognitive function (NIH-Toolbox Cognitive Battery) score

    Adjusted for score (Uncorrected Standard Score (59-140) Higher score indicates better cognitive performance) at randomization )

    Measured: At 18-mo post-randomization

  3. In the Nested Randomized Control Trial (RCT) - Biopsy Proven Acute Rejection (BPAR) efficacy failure

    Defined as time to first of: BPAR (including borderline), Death, Graft loss, Lost to follow up

    Measured: From randomization to 18-mo post-randomization

Timeline

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

  1. First posted26 Jun 2023
  2. Study start7 Dec 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2029 (estimated)

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
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917522
Sponsor's protocol ID
DAIT RTB-015
Status last verified
Mar 2026
First submitted
11 May 2023
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abatacept in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites 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 25 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In the Observational Study - The occurrence of any alloimmune event (time frame: Up to 24 months post-Kidney Transplant). The study lists 2 primary outcomes in all. 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 NCT05917522.

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 23 Mar 2026.

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