A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

UCB

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Chronic Allograft Injury

Treatments

Drug: Zampilimab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04335578

CAI001

2017-004807-31 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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