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TerminatedNCT04335578Updated Sep 21, 2022

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

A Phase 1/2 interventional study of Zampilimab and Placebo in Chronic Allograft Injury, sponsored by UCB Biopharma SRL. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by UCB Biopharma SRL · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Recruitment challenges

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2019, registered Apr 2020).
Phase
Phase 1/2
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Chronic Allograft Injury

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Keywords

  • Chronic Allograft Injury
  • UCB7858
  • Kidney transplantation
  • CAI
  • zampilimab
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 3 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Zampilimab Cohorts

    Participants will be randomized to receive zampilimab (UCB7858).

    Drug: Zampilimab

  • Placebo comparator
    Placebo

    Participants randomized to this arm will receive matching Placebo.

    Drug: Placebo

Interventions

  • DrugZampilimab

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

    Also known as: UCB7858

  • DrugPlacebo

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

    Also known as: PBO

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What researchers measure

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.

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

Secondary outcomes

  1. Serum concentration of zampilimab

    Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit

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

  2. Urine concentration of zampilimab

    Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit

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

07

Study locations

5 sites
  • Cai001 403
    Nedlands, Australia
  • Cai001 101
    Leuven, Belgium
  • Cai001 301
    Barcelona, Spain
  • Cai001 302
    Hospitalet de Llobregat, Spain
  • Cai001 501
    London, United Kingdom
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References and documents

Individual participant data

Plan to share: No — Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04335578
Lead sponsor
UCB Biopharma SRL
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Oct 21, 2019
Primary completion
May 4, 2022
Completion
May 4, 2022
Last update
Sep 21, 2022

Study contacts

UCB Cares
principal investigator · 001 844 599 2273

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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