A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

UCB Biopharma SRL5 sites in 4 countries3 target enrollmentOctober 21, 2019

ConditionsChronic Allograft Injury

InterventionsZampilimab Placebo

DrugsPlacebo Zampilimab

Overview

Phase: Phase 1
Intervention: Zampilimab
Conditions: Chronic Allograft Injury
Sponsor: UCB Biopharma SRL
Enrollment: 3
Locations: 5
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 21, 2019

End Date

May 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Biopharma SRL

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Zampilimab Cohorts

Participants will be randomized to receive zampilimab (UCB7858).

Intervention: Zampilimab

Placebo

Participants randomized to this arm will receive matching Placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame: 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 Outcomes

Serum concentration of zampilimab(From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680))
Urine concentration of zampilimab(From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680))