← Back to Search

Immunosuppressant

Immunosuppressive Therapy for Kidney Transplant in Children (ADVANTage Trial)

Phase 2

Recruiting

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

Must not have

Active infection requiring treatment, or viremia

Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I am between 13 and 20 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any infections that need treatment.

Select...

I have a kidney condition like FSGS, MPGN, C3 glomerulopathy, or atypical HUS.

Select...

I have had an organ transplant in the past.

Select...

I have a known bleeding disorder.

Select...

I have a genetic condition that makes my blood clot easily and I take medication for it beyond aspirin.

Select...

I have a serious heart condition from birth affecting my blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Anti-Thymocyte Globulin (ATG)

2014

Completed Phase 2

~90

Sirolimus

2013