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Evaluation of Conversion from Calcineurin Inhibitor- to Belatacept-based Immunosuppression in Adolescent Renal Transplant Recipients and their Compliance with Immunosuppressive Medications
EU CTIS ID: 2022-501677-39-00
What this study is testing
Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months post-randomization.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and females between 12 to less than 18 years of age
- Documented EBV seropositivity prior to transplant and randomization
- Receiving a stable regimen of a CNI with a mycophenolate with or without concomitant corticosteroids for > 1 calendar month prior to randomization
- Stable renal function 12 weeks prior to screening based upon investigator assessment and protocol-defined criteria for eGFR and proteinuria
You likely can't join if
- No treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
- No history of biopsy confirmed antibody mediated rejection or Banff Grade IIA or higher acute cellular rejection with the current transplant
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.