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

NCT04335578 | Terminated Phase 1

• 2 other identifiers: CAI0012017-004807-31
• Study Type: interventional
• Target: 3
• Locations: 4 countries
• Sites: 5

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).

Conditions

Chronic Allograft Injury

Keywords

Chronic Allograft Injury; UCB7858; Kidney transplantation; CAI; zampilimab

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  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.

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

Secondary Outcomes (2)

• 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)

Study Arms (2)

Zampilimab Cohorts

EXPERIMENTAL

Participants will be randomized to receive zampilimab (UCB7858).

Drug: Zampilimab

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive matching Placebo.

Drug: Placebo

Interventions

Zampilimab DRUG

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

Also known as: UCB7858

Zampilimab Cohorts

Placebo DRUG

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

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (5)

Cai001 403

Nedlands, Australia

Location

Cai001 101

Leuven, Belgium

Location

Cai001 301

Barcelona, Spain

Location

Cai001 302

L'Hospitalet de Llobregat, Spain

Location

Cai001 501

London, United Kingdom

Location

Related Publications (1)

• Zhou X, Trinh-Minh T, Matei AE, Gyorfi AH, Hong X, Bergmann C, Schett G, Atkinson J, Bowcutt R, Patel J, Johnson TS, Distler JHW. Amelioration of Fibrotic Remodeling of Human 3-Dimensional Full-Thickness Skin by Transglutamase 2 Inhibition. Arthritis Rheumatol. 2023 Sep;75(9):1619-1627. doi: 10.1002/art.42518. Epub 2023 Jul 5.

  PMID: 37057394 DERIVED

Study Officials

• UCB Cares

  001 844 599 2273

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an Investigator-blind and participant-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: October 21, 2019
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); ES (2); GB (1); BE (1)