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Immunosuppressant

Immunosuppressive Therapy for Kidney Transplant in Children (ADVANTage Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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) at time of enrollment

Candidate for primary renal allograft from a deceased donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years post-transplant

Awards & highlights

ADVANTage Trial Summary

This trial will compare two treatments for kidney transplants in 200 children. Results will be compared over 12-24 months.

Who is the study for?

This trial is for children aged 13-20 who need a kidney transplant from a deceased donor. They must be able to consent, have immunity to EBV (a type of virus), and use birth control if applicable. Kids under 6 or with living donors might join later if it's safe.Check my eligibility

What is being tested?

The study compares two drug combos after kidney transplants in kids: belatacept & sirolimus vs tacrolimus & mycophenolate mofetil. It's random which one they get, and they'll be watched for up to two years to see how well the drugs prevent organ rejection.See study design

What are the potential side effects?

Possible side effects include increased risk of infections due to weakened immune systems, potential damage to kidneys or other organs from the drugs, allergic reactions, and problems related to blood cells like anemia or clotting issues.

ADVANTage Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have immunity to Epstein-Barr virus as shown by specific blood tests.

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I am waiting for a kidney transplant from a deceased donor.

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I am between 13 and 20 years old.

ADVANTage Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

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

Incidence of Post-Transplant Lymphoproliferative Disease (PTLD)

Incidence of clinical biopsy proven allograft rejection (central lab)

+5 more

ADVANTage Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: (Group 1): Belatacept+Sirolimus groupExperimental Treatment4 Interventions

Participants in this group will receive antithymocyte globulin (ATG) + steroid taper + belatacept + (tacrolimus bridge, day 0-14) with conversion to sirolimus (day 30 +/-14 days)

Group II: (Group 2): Tacrolimus + Mycophenolate Mofetil (MMF) groupActive Control3 Interventions

Participants in this group will receive anti-thymocyte globulin (ATG) + steroid taper + tacrolimus + MMF

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

2013

Completed Phase 4

~2750

Belatacept

2013

Completed Phase 4

~2210

Anti-Thymocyte Globulin (ATG)

2014

Completed Phase 2

~90

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,269 Total Patients Enrolled

Eileen Chambers, MDStudy ChairDuke University Medical Center: Department of Pediatrics

1 Previous Clinical Trials

22 Total Patients Enrolled

David Briscoe, MDStudy ChairBoston Children's Hospital: Pediatric Transplantation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to seniors aged 80 and above in this clinical trial?

"This clinical trial is seeking participants who are over 13 years of age and not yet 20."

Answered by AI

Does the Belatacept+Sirolimus combination possess regulatory approval from the FDA?

"Our team has rated the safety of Belatacept+Sirolimus as a 2 since it is currently being evaluated in Phase 2 trials, indicating that there are limited data points supporting its efficacy."

Answered by AI

Could I partake in this investigation?

"This clinical trial is seeking to enrol 200 patients with a kidney transplant from the age bracket of 13-20 years old."

Answered by AI

Are there currently any opportunities for individuals to join this particular research study?

"The clinicaltrial.gov registry reflects that this particular study, which was originally launched on November 1st 2023, is not presently recruiting patients. However, 79 other medical trials are open to enrollment at the current moment in time."

Answered by AI

At what geographical sites is the experiment being conducted?

"There are 18 clinical trial sites associated with this study, including Children's Hospital Los Angeles: Pediatric Transplantation in Los Angeles, Cedars Sinai Medical Center: Pediatric Transplantation in San Diego and Ronald Reagan UCLA Medical Center: Pediatric Transplantation in Aurora. Additional medical centres also exist across the United States of America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Advancing Transplantation Outcomes in Children

2024. "Advancing Transplantation Outcomes in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055608.

All > Kidney Transplant