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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

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

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