Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04335578




Registration number
NCT04335578
Ethics application status
Date submitted
3/04/2020
Date registered
6/04/2020
Date last updated
21/09/2022

Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Scientific 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
Secondary ID [1] 0 0
2017-004807-31
Secondary ID [2] 0 0
CAI001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Allograft Injury 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zampilimab
Treatment: Drugs - Placebo

Experimental: Zampilimab Cohorts - Participants will be randomized to receive zampilimab (UCB7858).

Placebo Comparator: Placebo - Participants randomized to this arm will receive matching Placebo.


Treatment: Drugs: Zampilimab
Participants will receive zampilimab (UCB7858) at pre-specified time-points.

Treatment: Drugs: Placebo
Participants will receive matching placebo (PBO) at pre-specified time-points.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary outcome [1] 0 0
Serum concentration of zampilimab
Timepoint [1] 0 0
From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary outcome [2] 0 0
Urine concentration of zampilimab
Timepoint [2] 0 0
From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/05/2022
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cai001 403 - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Hospitalet de Llobregat
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Biopharma SRL
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04335578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04335578