Chronic Allograft Injury
Conditions
Keywords
Chronic Allograft Injury, UCB7858, Kidney transplantation, CAI, zampilimab
Brief summary
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).
Interventions
DRUGZampilimab
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
DRUGPlacebo
Participants will receive matching placebo (PBO) at pre-specified time-points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an Investigator-blind and participant-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Functioning living or deceased donor allograft \>=1 year post-transplantation * Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (\>=25% IF/TA) * Progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (eGFR) decline of ≥3 mL/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart) * An eGFR \>=30 mL/min/1.73 m\^2 for a period of 6 months up to screening * Stable standard of care concomitant medication for 3 months prior to screening * Participant is male or female, \>=18 years of age
Exclusion criteria
* Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients) * Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI) * Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI * Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI * Proteinuria ≥1500 mg/g at screening * Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening * Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP) * Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing * Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of zampilimab | From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) | Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit |
| Urine concentration of zampilimab | From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) | Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit |
Countries
Australia, Belgium, Spain, United Kingdom
Outcome results
None listed