Who is eligible for clinical trial NCT06055608?

Participants must meet the protocol's inclusion criteria for Kidney Transplant. The stated age range is 13 Years to 20 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06055608 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-19

Advancing Transplantation Outcomes in Children (NCT06055608)

Advancing Transplantation Outcomes in Children (CTOT-41)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (28 items).

Location: University of Alabama at Birmingham (Site # 71038) — Birmingham, Alabama

Age range: 13 Years to 20 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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)
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

University of Alabama at Birmingham (Site # 71038) — Birmingham, Alabama
Children's Hospital of Los Angeles (Site #: 71036) — Los Angeles, California
Cedars-Sinai Medical Center (Site #: 71026) — Los Angeles, California
Mattel Children's Hospital, UCLA (Site #: 71012) — Los Angeles, California
UCSD Rady Children's Hospital (Site #: 71037) — San Diego, California
Children's Hospital of Colorado (Site #: 71019) — Aurora, Colorado
Nemours Children's Health (Site #: 71042) — Wilmington, Delaware
Children's National Medical Center (Site #: 71039) — Washington D.C., District of Columbia
Ann and Robert H. Lurie Children's Hospital of Chicago (Site #: 71016) — Chicago, Illinois
Johns Hopkins Children's Center (Site #: 71025) — Baltimore, Maryland
Boston Children's Hospital (Site #: 71001) — Boston, Massachusetts
Helen DeVos Children's Hospital (Site #: 71035) — Grand Rapids, Michigan
Washington University/St. Louis Children's Hospital (Site #: 71006) — St Louis, Missouri
New York Medical College/Boston Children's Health Physicians — Westchester, New York
Duke University (Site #: 71033) — Durham, North Carolina
Cincinnati Children's Hospital Medical Center (Site #: 71017) — Cincinnati, Ohio
Children's Hospital of Philadelphia (Site #: 71091) — Philadelphia, Pennsylvania
UPMC Children's Hospital of Pittsburgh (Site #: 71008) — Pittsburgh, Pennsylvania
Texas Children's Hospital (Baylor) (Site #: 71005) — Houston, Texas
Seattle Children's Hospital (Site #: 71041) — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (205) 638-9781

Email: whouse@uabmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Kidney Transplant

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study — Pittsburgh, Pennsylvania
CAR-T Cell Therapy for Desensitization in Kidney Transplantation — Boston, Massachusetts
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation — Birmingham, Alabama
Social Support Counseling Intervention for Kidney Transplant Candidates — Minneapolis, Minnesota
Empagliflozin Treatment in Kidney Transplant Recipients — Hines, Illinois
Phenotype Guided Vasoactive Medication During Kidney Transplantation — Los Angeles, California

Explore by condition: All Kidney Transplant clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗