AzTrials
AzTrials

Kidney TransplantPhase 2ADVANTageNCT06055608

Advancing Transplantation Outcomes in Children

A Phase 2 study testing Sirolimus, Belatacept and Mycophenolate Mofetil in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.

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

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. Read more about this study

Who is it for?
Ages 13 to 20 years
Conditions the study is for
Kidney Transplant
What is being tested?
Sirolimus, Belatacept and Mycophenolate Mofetil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
21 sitesin 2 countries
Study dates
22 May 2024to 30 Jun 2028
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 13 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant and/or parent/guardian must be able to understand and provide informed consent
  • Male or female, 13-20 years of age at time of enrollment
  • Candidate for primary renal allograft from a living or deceased donor
  • EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)
  • EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior to enrollment
  • If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures
Show all 10Show fewer
  • If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study
  • Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative [PPD]) or Tuberculosis (TB) blood test (interferon gamma release assay [IGRA] i.e., QuantiFERON, T- SPOT.TB) within 12 months
  • In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
  • Enrollment criteria for donor source and age will be expanded using a stepwise approach determined by safety monitoring. Expansion criteria will include recipients down to age 6 and living donors. Safety data from each step will be reviewed by the study team, DSMB and FDA. If no safety concerns are identified, inclusion criteria will be expanded.

Who cannot join

  • Inability or unwillingness to comply with study protocol
  • Active infection requiring treatment, or viremia
  • History of malignancy
  • Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment
  • Prior history of organ transplantation
  • Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)
Show all 32Show fewer
  • Active systemic autoimmune disease at time of enrollment
  • Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence
  • Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment
  • Known bleeding disorder
  • Sustained platelet count < 75,000 cells/microliters within 3 months of enrollment
  • History of inherited hypercoagulability requiring therapy more than aspirin
  • Panel Reactive Antibody (cPRA) greater than 80 percent
  • Clinically significant unrepaired congenital heart disease causing hemodynamic compromise
  • Uncontrolled diagnosed psychiatric disorder 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
  • 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
  • Randomization Inclusion Criteria:
  • Individuals who meet all of the following criteria are eligible for randomization.
  • 1. If EBV serology to meet enrollment criteria was performed within 8 weeks of receiving IVIG, EBV VCA IgG and EBV EBNA IgG seropositivity, confirmed between enrollment and time of transplant
  • Randomization Exclusion Criteria:
  • Individuals who meet any of these criteria are not eligible for randomization.
  • Sustained WBC <1500 or >20,000 per microliter within 3 months of randomization
  • Sustained liver function tests (AST and/or ALT) > 2x normal within 3 months of randomization
  • Active systemic autoimmune disease at time of transplant
  • Known bleeding disorder
  • Sustained platelet count < 75,000 cells/microliters within 3 months of enrollment
  • Current (within 45 days) or historical anti-HLA antibody to the donor prior to randomization
  • Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization
  • Panel Reactive Antibody (cPRA) greater than 80 percent at any point in time
  • If a female participant of childbearing potential, a positive pregnancy test within 48 hours of randomization (all female participants of childbearing potential must complete a pregnancy test within 48 hours of randomization)
  • Treatment with immunosuppressants within 8 weeks of randomization, except in the case of planned transplant standard of care
  • Treatment with biologics (including IVIG) within 8 weeks of randomization

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

21 sites in 2 countries

United States20 sites, 20 recruiting

  • Children's Hospital of Colorado (Site #: 71019)

    Aurora, Colorado, 80045

    Claire Giachino, 720-770-0107, Claire.Giachino@childrenscolorado.org

    Recruiting

  • Johns Hopkins Children's Center (Site #: 71025)

    Baltimore, Maryland, 21287

    Ryan Hutson, 443-287-3214, rhutson1@jhmi.edu

    Recruiting

  • University of Alabama at Birmingham (Site # 71038)

    Birmingham, Alabama, 35233

    Scott House, 205-638-9781, whouse@uabmc.edu

    Recruiting

  • Boston Children's Hospital (Site #: 71001)

    Boston, Massachusetts, 02215

    Emily Toal, MPH, 617-919-6535, emily.toal@childrens.harvard.edu

    Recruiting

  • Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016)

    Chicago, Illinois, 60611

    Petula Grant, 312-227-7401, pgrant@luriechildrens.org

    Recruiting

  • Cincinnati Children's Hospital Medical Center (Site #: 71017)

    Cincinnati, Ohio, 45229

    Nina Kanis, 513-803-1053, Nina.Kanis@cchmc.org

    Recruiting

  • Duke University (Site #: 71033)

    Durham, North Carolina, 27710

    Hannah Joy Porter, 919-684-0356, hanajoy.porter@duke.edu

    Recruiting

  • Helen DeVos Children's Hospital (Site #: 71035)

    Grand Rapids, Michigan, 49503

    Lena Sanfilippo, 616-391-4305, lena.sanfilippo@corewellhealth.org

    Recruiting

  • Texas Children's Hospital (Baylor) (Site #: 71005)

    Houston, Texas, 77030

    Irina Dinu, 832-824-3388, irina.dinu@bcm.edu

    Recruiting

  • Children's Hospital of Los Angeles (Site #: 71036)

    Los Angeles, California, 90027

    Ariana Teame, 1-323-419-2774, ateame@chla.usc.edu

    Not yet recruiting

  • Cedars-Sinai Medical Center (Site #: 71026)

    Los Angeles, California, 90048

    Kelly Kirshner, 310-825-0922, Kelly.kirshner@cshs.org

    Recruiting

  • Mattel Children's Hospital, UCLA (Site #: 71012)

    Los Angeles, California, 90095

    Serena Ridge, 1-310-968-4225, SRidge@mednet.ucla.edu

    Recruiting

  • Children's Hospital of Philadelphia (Site #: 71091)

    Philadelphia, Pennsylvania, 19104

    Annie Chung, 267-425-3934, Chunga@chop.edu

    Recruiting

  • UPMC Children's Hospital of Pittsburgh (Site #: 71008)

    Pittsburgh, Pennsylvania, 15224

    Vibha Chauhan, 412-692-6739, vibha.chauhan@chp.edu

    Recruiting

  • UCSD Rady Children's Hospital (Site #: 71037)

    San Diego, California, 92123

    Kristin Zeeb, 858-966-1700 ext. 221657, kzeeb@health.ucsd.edu

    Recruiting

  • Seattle Children's Hospital (Site #: 71041)

    Seattle, Washington, 98105

    Megan Kelton, 206-987-5539, megan.kelton@seattlechildrens.org

    Recruiting

  • Washington University/St. Louis Children's Hospital (Site #: 71006)

    St Louis, Missouri, 63110

    Lujain Jaza, 314-747-1846, jaza@wustl.edu

    Recruiting

  • Children's National Medical Center (Site #: 71039)

    Washington D.C., District of Columbia, 20010

    Mirian Naybor, 202-476-6659, mnaybor@childrensnational.org

    Recruiting

  • New York Medical College/Boston Children's Health Physicians

    Westchester, New York, 10461

    Armando Ramirez, (914) 504-0152, Armando_Ramirez@bchphysicians.org

    Zachary Messer, Zachary_Messer@bchphysicians.org

    Not yet recruiting

  • Nemours Children's Health (Site #: 71042)

    Wilmington, Delaware, 19803

    Aiyana Bullock, 302-274-9333, aiyana.bullock@nemours.org

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • British Columbia Children's Hospital (Site #: 71034)

    Vancouver, British Columbia, V5Z 4H4

    Mattias Hui, 1-604-875-2000, mattias.hui@bcchr.ca

    Recruiting

Other trials in Canada

About this study

Official title: Advancing Transplantation Outcomes in Children (CTOT-41)

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Being tested
Sirolimus, Belatacept, Mycophenolate Mofetil, Tacrolimus (Group1), Anti-Thymocyte Globulin (ATG)
Keywords
kidney transplant, belatacept, sirolimus

What participants receive

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

  • SirolimusDrug

    Also called AY 22-989, Rapamune, Rapamycin

    Participants in Group 1 will transition to sirolimus therapy on day 14 (+/- 5 days) - weight <40 kg will receive 3mg/m^ 2, with maintenance dose of 1 mg/m^2 divided BID - weight >= 40kg will receive 6mg/m^ 2, with maintenance dose of 2 mg daily

  • BelataceptBiological

    Also called Nulojix

    Belatacept will be administered as an intravenous infusion over 30 minutes. The belatacept dose for the study is 10 mg/kg on post-operative day (POD) 1, 5, 14, 28, 56, 84 for the first 3 months, followed by 5 mg/kg every 4 weeks (+/-4 days), starting on month 4 until month 24

  • Mycophenolate MofetilDrug

    Also called CellCept, MMF

    Mycophenolate Mofetil-MMF will be initiated at 600 mg/m^2 BID until tacrolimus is at therapeutic levels, then 450 mg/m^2 BID

  • Tacrolimus (Group1)Drug

    Also called FK-506, FR-900506, Prograf

    Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels. Participants in Group 1 will be transitioned to sirolimus 2-4 weeks post-transplant

  • Anti-Thymocyte Globulin (ATG)Drug

    Participants will receive induction therapy with anti-thymocyte globulin (1.5 mg/kg/dose, maximum 125 mg) starting intraoperatively on day 0 and continuing on days 2 and 3 (total dose 4.5 mg/kg). Total dose may be extended to 6 mg/kg over 1-2 days for delayed graft function

  • Tacrolimus (Group 2)Drug

    Also called FK-506, FR-900506, Prograf

    Participants will receive Prograf® (tacrolimus), or generic, initiated at 0.1 mg/kg BID within 48 hours of transplantation to attain target trough levels

Study groups in NCT06055608
Study groupRoleWhat they receive
(Group 1): Belatacept+Sirolimus groupExperimentalParticipants in this group will receive antithymocyte globulin (ATG) + steroid taper + belatacept + (tacrolimus bridge, day 0-14) with conversion to sirolimus (day 30 +/-14 days)
Receives: Drug: Sirolimus; Biological: Belatacept; Drug: Tacrolimus (Group1); Drug: Anti-Thymocyte Globulin (ATG)
(Group 2): Tacrolimus + Mycophenolate Mofetil (MMF) groupActive comparatorParticipants in this group will receive anti-thymocyte globulin (ATG) + steroid taper + tacrolimus + MMF
Receives: Drug: Mycophenolate Mofetil; Drug: Anti-Thymocyte Globulin (ATG); Drug: Tacrolimus (Group 2)

What is being measured

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

  1. Incidence of de novo Donor Specific Antibody (dnDSA) (central lab) OR decline in estimated glomerular filtration rate (eGFR) >7.5 mL/min/1.73m^2 (central lab)

    Measured: At 96 weeks post-transplant

Secondary outcomes (8)

  1. Incidence of clinical biopsy proven allograft rejection (central lab)

    Measured: Within 96 weeks post-transplant

  2. Time to development of clinical biopsy proven allograft rejection (central lab)

    Measured: Within 96 weeks post-transplant

  3. Incidence of subclinical biopsy proven allograft rejection (central lab)

    Measured: Within 96 weeks post-transplant

  4. Time to development of subclinical biopsy proven allograft rejection (central lab)

    Measured: Within 96 weeks post-transplant

  5. Incidence of Post-Transplant Lymphoproliferative Disease (PTLD)

    Measured: Within 96 weeks post-transplant

  6. Time to development of the PTLD

    Measured: Within 96 weeks post-transplant

  7. Incidence of Grade 3 and above opportunistic infections bacterial, viral, fungal, pneumocystis pneumonia, or parasitic infections assessed as a composite

    Measured: Within 96 weeks post-transplant

  8. Time to development of Grade 3 and above opportunistic infections bacterial, viral, fungal, pneumocystis pneumonia, or parasitic infections assessed as a composite

    Measured: Within 96 weeks post-transplant

Timeline

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

  1. First posted28 Sep 2023
  2. Study start22 May 2024
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055608
Sponsor's protocol ID
DAIT CTOT-41
Acronym
ADVANTage
Status last verified
Oct 2026
First submitted
20 Sep 2023
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sirolimus, Belatacept and Mycophenolate Mofetil in people with Kidney Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.

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 10 inclusion and 32 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. 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?

Incidence of de novo Donor Specific Antibody (dnDSA) (central lab) OR decline in estimated glomerular filtration rate (eGFR) >7.5 mL/min/1.73m^2 (central lab) (time frame: At 96 weeks post-transplant). 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 NCT06055608.

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 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in