CAI001
CAI001
A 2-Stage, Multicenter, Randomized, Placebo-Controlled Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Efficacy of UCB7858 in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Brief summary
The main purpose of Stage 1 in this study is to investigate the safety and tolerability of UCB7858 in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI) and to determine the dose level for Stage 2. The main purpose of Stage 2 is to further investigate the safety, tolerability, and efficacy of repeat dosing with UCB7858 in kidney transplant recipients with deteriorating kidney function associated with CAI.Medical Condition
Chronic Allograft Injury
Min. Age
18
Years
Max. Age
-
Who Can Join?
All
Status
Recruiting
Inclusion criteria
-Functioning 1st donor allograft >=1 year post-transplantation
-Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
-Progressive decline in kidney function defined as estimated glomerular filtration rate (eGFR) decline >=5% during the 9 months prior to screening
-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 dual kidney transplant recipients, and/or corneal transplant recipients)
-Screening biopsy shows evidence of significant antibody-mediated rejection
-Screening biopsy shows evidence of T cell-mediated rejection classified Banff Grade >=I
-Screening biopsy shows evidence of de novo or recurrent glomerular disease
-Screening biopsy shows severe transplant glomerulopathy lesions defined as chronic glomerulopathy (cg) score of 3
-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
-Participant has a history of wound healing complications
-Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
Study Medication Description
Study Medication:
zampilimab
Other Descriptive Name:
UCB7858
Placebo
Yes
Comparator:
No
Refer to a friend
Study Dates
October 2019
Actual Start Date of Enrollment
October 2023
Planned Study Completion Date
General Information
Study ID:
CAI001
EudraCT Number:
2017-004807-31
CT.gov Number:
NCT04335578
Phase:
Phase 1/Phase 2