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NCT06055608 · ClinicalTrials.gov registry record · Phase 2

Advancing Transplantation Outcomes in Children

A Phase 2 study of Kidney Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
20
Study locations

NCT06055608 is a Phase 2 study of Kidney Transplant that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants, below the 1,892-participant average among 30 other Kidney Transplant trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT06055608, a Phase 2 study of Kidney Transplant, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
20
Study locations

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

What the Registry Record Tells You About NCT06055608

The ClinicalTrials.gov registry entry for NCT06055608 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,892-participant average among 30 other Kidney Transplant trials with a reported enrollment target (89% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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.

NCT06055608 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Pennsylvania, Alabama.

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.

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).

Who is sponsoring clinical trial NCT06055608?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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.

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

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