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RECRUITING Phase 2

Advancing Transplantation Outcomes in Children

NCT06055608 · View on ClinicalTrials.gov ↗

Study 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. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Conditions Studied

Interventions

  • DRUG Sirolimus
  • DRUG Mycophenolate Mofetil
  • BIOLOGICAL Belatacept
  • DRUG Tacrolimus (Group1)
  • DRUG Anti-Thymocyte Globulin (ATG)

Study Locations (20)

California

  • Children's Hospital of Los Angeles (Site #: 71036) — Los Angeles
  • Cedars-Sinai Medical Center (Site #: 71026) — Los Angeles
  • Mattel Children's Hospital, UCLA (Site #: 71012) — Los Angeles
  • UCSD Rady Children's Hospital (Site #: 71037) — San Diego

Pennsylvania

  • Children's Hospital of Philadelphia (Site #: 71091) — Philadelphia
  • UPMC Children's Hospital of Pittsburgh (Site #: 71008) — Pittsburgh

Alabama

  • University of Alabama at Birmingham (Site # 71038) — Birmingham

Colorado

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

Delaware

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

District of Columbia

  • Children's National Medical Center (Site #: 71039) — Washington D.C.

Illinois

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

Maryland

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

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2024-05-22
Est. Completion 2028-06-30
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06055608

The ClinicalTrials.gov registry entry for NCT06055608 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Kidney Transplant appearing as the primary indexed condition, and to 5 interventions — of which Sirolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06055608 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06055608 about?

NCT06055608 is a clinical study titled "Advancing Transplantation Outcomes in Children". 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 pro...

What is the current status of trial NCT06055608?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-05-22. Estimated completion is 2028-06-30.

What conditions does trial NCT06055608 study?

This clinical trial studies the following conditions: Kidney Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06055608?

The interventions under investigation include: Sirolimus (DRUG), Mycophenolate Mofetil (DRUG), Belatacept (BIOLOGICAL), Tacrolimus (Group1) (DRUG), Anti-Thymocyte Globulin (ATG) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06055608?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06055608 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial