Back to resultsA Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Primary Purpose
Chronic Allograft Injury
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Zampilimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Allograft Injury focused on measuring Chronic Allograft Injury, UCB7858, Kidney transplantation, CAI, zampilimab
Eligibility 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
Sites / Locations
- Cai001 403
- Cai001 101
- Cai001 301
- Cai001 302
- Cai001 501
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zampilimab Cohorts
Placebo
Arm Description
Participants will be randomized to receive zampilimab (UCB7858).
Participants randomized to this arm will receive matching Placebo.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Serum concentration of zampilimab
Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Urine concentration of zampilimab
Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04335578
Brief Title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
May 4, 2022 (Actual)
Study Completion Date
May 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allograft Injury
Keywords
Chronic Allograft Injury, UCB7858, Kidney transplantation, CAI, zampilimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is an Investigator-blind and participant-blind study.
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zampilimab Cohorts
Arm Type
Experimental
Arm Description
Participants will be randomized to receive zampilimab (UCB7858).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will receive matching Placebo.
Intervention Type
Drug
Intervention Name(s)
Zampilimab
Other Intervention Name(s)
UCB7858
Intervention Description
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Participants will receive matching placebo (PBO) at pre-specified time-points.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
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 Outcome Measure Information:
Title
Serum concentration of zampilimab
Description
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)
Title
Urine concentration of zampilimab
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cai001 403
City
Nedlands
Country
Australia
Facility Name
Cai001 101
City
Leuven
Country
Belgium
Facility Name
Cai001 301
City
Barcelona
Country
Spain
Facility Name
Cai001 302
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Cai001 501
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
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