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

• ClinicalTrials.gov Identifier: NCT04335578
• Recruitment Status: Terminated
• First Posted: April 6, 2020
• Last Update Posted: September 21, 2022
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: This is an Investigator-blind and participant-blind study.
• 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
• Actual Primary Completion Date: May 4, 2022
• Actual Study Completion Date: May 4, 2022

Arms and Interventions

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 (PBO) at pre-specified time-points.; Other Name: PBO

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Australia

Cai001 403

Nedlands, Australia

Belgium

Cai001 101

Leuven, Belgium

Spain

Cai001 301

Barcelona, Spain

Cai001 302

Hospitalet de Llobregat, Spain

United Kingdom

Cai001 501

London, United Kingdom

Sponsors and Collaborators

UCB Biopharma SRL

Investigators

• Principal Investigator: UCB Cares; 001 844 599 2273

More Information

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT04335578
• Other Study ID Numbers: CAI001; 2017-004807-31 ( EudraCT Number )
• First Posted: April 6, 2020
• Last Update Posted: September 21, 2022
• Last Verified: September 2022

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.

• 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:

Wounds and Injuries