The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
Participants will receive matching placebo (PBO) at pre-specified time-points.
Cai001 403
Nedlands, Australia
Cai001 101
Leuven, Belgium
Cai001 301
Barcelona, Spain
Cai001 302
L'Hospitalet de Llobregat, Spain
Cai001 501
London, United Kingdom
Incidence of treatment-emergent adverse events (TEAEs)
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.
Time frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Serum concentration of zampilimab
Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Time frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Urine concentration of zampilimab
Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Time frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
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