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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2022-05-04

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Allograft Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is an Investigator-blind and participant-blind study.

Study Groups

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Zampilimab Cohorts

Participants will be randomized to receive zampilimab (UCB7858).

Group Type EXPERIMENTAL

Zampilimab

Intervention Type DRUG

Participants will receive zampilimab (UCB7858) at pre-specified time-points.

Placebo

Participants randomized to this arm will receive matching Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive matching placebo (PBO) at pre-specified time-points.

Interventions

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Zampilimab

Participants will receive zampilimab (UCB7858) at pre-specified time-points.

Intervention Type DRUG

Placebo

Participants will receive matching placebo (PBO) at pre-specified time-points.

Intervention Type DRUG

Other Intervention Names

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UCB7858 PBO

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No