IM103-402 Conversion to Belatacept-based Immunosuppression in Adolescent Renal Transplant Recepients
Research type
Research Study
Full title
A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of IM103-402: Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
IRAS ID
1003511
Contact name
Jon Jin Kim
Contact email
Eudract number
2018-000237-12
Clinicaltrials.gov Identifier
Research summary
Kidney transplantation is the treatment for most patients with end stage renal disease, and requires the use of anti-rejection medications for transplant survival. These medications have varied safety profiles and off-target effects that may have an adverse impact on quality of life and result in patients not complying with the regimens. Adolescent kidney transplant recipients are at higher risk of graft rejection due to lack of medication compliance.
Belatacept was developed to address the medical need for a new anti-rejection therapy for kidney transplant recipients that can avoid the renal, cardiovascular, or metabolic toxicities of existing calcineurin inhibitor (CNI)-based regimens, while offering similar short-term patient and graft survival. CNIs may also be associated with adverse effects on neurological or cognitive function that may impact work or school, as well as some effects on physical appearance that may prevent regular adherence to a prescribed oral dosing regimen.
Belatacept is administered by infusion in a vein every 4 weeks.
This is an open-label study that will evaluate the benefits and risks of conversion from CNI-to-belatacept-based immunosuppression following a 3-6-month CNI taper (slowly reducing medication) when compared to remaining on CNI-based immunosuppression in adolescent kidney transplant recipients.
Subjects: female/male adolescents 12 to less than 18 years; recipients of a kidney transplanted at least 6 months prior to enrollment.
Eligible subjects are randomized to:
Arm 1: Belatacept on Days 1, 15, 29, 43, 57, then every 28 days. The CNI dose will be reduced and stopped during 12-24 weeks after Day 1.
Arm 2: Continue CNI treatment.
Procedures:
Physical examination
• Vital signs
• Chest x-ray if needed
• ECG
• Pregnancy test if applicable
• Blood draws
• Urine sample
• Coronavirus test (Nasal swab)
• 2 questionnaires
• Blood draw + biopsy (rejection)
Follow-up visit at week 8 after last dose of study medication.REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0037
Date of REC Opinion
19 Aug 2021
REC opinion
Further Information Favourable Opinion