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Trial record 1 of 1 for:    NCT04335578
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A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

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ClinicalTrials.gov Identifier: NCT04335578
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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).

Condition or disease Intervention/treatment Phase
Chronic Allograft Injury Drug: Zampilimab Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an Investigator-blind and participant-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zampilimab Cohorts
Participants will be randomized to receive zampilimab (UCB7858).
Drug: Zampilimab
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
Other Name: UCB7858

Placebo Comparator: Placebo
Participants randomized to this arm will receive matching Placebo.
Drug: Placebo
Participants will receive matching placebo at pre-specified time-points.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Serum concentration of zampilimab [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) ]
    Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit

  2. Urine concentration of zampilimab [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) ]
    Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335578


Contacts
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Contact: UCB Cares 001 844 599 2273 UCBCares@ucb.com

Locations
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Australia
Cai001 401 Withdrawn
Adelaide, Australia
Cai001 403 Completed
Nedlands, Australia
Cai001 402 Withdrawn
Randwick, Australia
Belgium
Cai001 101 Recruiting
Leuven, Belgium
Germany
Cai001 201 Withdrawn
Berlin, Germany
Spain
Cai001 301 Recruiting
Barcelona, Spain
Cai001 302 Recruiting
Barcelona, Spain
United Kingdom
Cai001 501 Recruiting
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Principal Investigator: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04335578    
Other Study ID Numbers: CAI001
2017-004807-31 ( EudraCT Number )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Chronic Allograft Injury
UCB7858
Kidney transplantation
CAI
zampilimab
Additional relevant MeSH terms:
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Wounds and Injuries