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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04335578
Ethics application status
Date submitted
3/04/2020
Date registered
6/04/2020
Date last updated
6/11/2020

Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of UCB7858 in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Scientific title
A 2-Stage, Multicenter, Randomized, Placebo-Controlled Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Efficacy of UCB7858 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) or Placebo in order to maintain the blinding. The dose for Stage 2 will be informed by DMC recommendation based on Stage 1 data.

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


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

Treatment: Drugs: Placebo
Participants will receive matching placebo at pre-specified time-points to maintain the blinding.

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) (Stages 1 and 2) - 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
Timepoint [1] 0 0
From Day 1 (Baseline) to the end of Safety Follow-up (up to Day 505 for Stage 1 and up to Day 477 for Stage 2)
Primary outcome [2] 0 0
Rate of change in estimated Glomerular Filtration Rate (eGFR) value over time (Stage 2) - Estimated Glomerular Filtration Rate (eGFR) is a measure of kidney function and is calculated using the CKD-EPI Creatinine Equation based on a patient's serum creatinine level, age, sex and race.
Timepoint [2] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [1] 0 0
Observed estimated Glomerular Filtration Rate (eGFR) value over time (Stages 1 and 2) - Estimated Glomerular Filtration Rate (eGFR) is a measure of kidney function and is calculated using the CKD-EPI Creatinine Equation based on a patient's serum creatinine level, age, sex and race.
Timepoint [1] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [2] 0 0
Change from Baseline in eGFR over time (Stages 1 and 2) - Estimated Glomerular Filtration Rate (eGFR) is a measure of kidney function and is calculated using the CKD-EPI Creatinine Equation based on a patient's serum creatinine level, age, sex and race.
Timepoint [2] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [3] 0 0
Percentage change from Baseline in eGFR over time (Stages 1 and 2) - Estimated Glomerular Filtration Rate (eGFR) is a measure of kidney function and is calculated using the CKD-EPI Creatinine Equation based on a patient's serum creatinine level, age, sex and race.
Timepoint [3] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [4] 0 0
Observed protein:creatinine ratio (PCR) over time (Stages 1 and 2) - The change in the ratio of urine protein excretion to creatinine is measured using PCR.
Timepoint [4] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [5] 0 0
Change from Baseline in PCR over time (Stages 1 and 2) - The change in the ratio of urine protein excretion to creatinine is measured using PCR.
Timepoint [5] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [6] 0 0
Percentage change from Baseline in PCR over time (Stages 1 and 2) - The change in the ratio of urine protein excretion to creatinine is measured using PCR.
Timepoint [6] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [7] 0 0
Time to graft failure (Stages 1 and 2) - Time to graft failure (eGFR of =15 mL/min/1.73m^2) is calculated as the time in days from the first dose of study treatment until graft failure during the Treatment Period.
Timepoint [7] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [8] 0 0
Serum concentration of UCB7858 (Stages 1 and 2) - Serum concentration of the drug UCB7858 during Stage 1 and Stage 2
Timepoint [8] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)
Secondary outcome [9] 0 0
Urine concentration of UCB7858 (Stages 1 and 2) - Urine concentration of the drug UCB7858 during Stage 1 and Stage 2
Timepoint [9] 0 0
From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337)

Eligibility
Key inclusion criteria
- Functioning 1st donor allograft >=1 year post-transplantation

- Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular
atrophy (IF/TA) (>=25% IF/TA)

- Progressive decline in kidney function defined as estimated glomerular filtration rate
(eGFR) decline >=5% during the 9 months prior to screening

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recipient of multi-organ transplant (with the exception of dual kidney transplant
recipients, and/or corneal transplant recipients)

- Screening biopsy shows evidence of significant antibody-mediated rejection

- Screening biopsy shows evidence of T cell-mediated rejection classified Banff Grade
>=I

- Screening biopsy shows evidence of de novo or recurrent glomerular disease

- Screening biopsy shows severe transplant glomerulopathy lesions defined as chronic
glomerulopathy (cg) score of 3

- 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

- Participant has a history of wound healing complications

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cai001 401 - Adelaide
Recruitment hospital [2] 0 0
Cai001 403 - Nedlands
Recruitment hospital [3] 0 0
Cai001 402 - Randwick
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Spain
State/province [3] 0 0
Barcelona

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 Stage 1 in this study is to investigate the safety and tolerability of
UCB7858 in kidney transplant recipients with deteriorating kidney function associated with
chronic allograft injury (CAI) and to determine the dose level for Stage 2. The main purpose
of Stage 2 is to further investigate the safety, tolerability, and efficacy of repeat dosing
with UCB7858 in kidney transplant recipients with deteriorating kidney function associated
with CAI.
Trial website
https://clinicaltrials.gov/show/NCT04335578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
UCB Cares
Address 0 0
Country 0 0
Phone 0 0
001844599
Fax 0 0
Email 0 0
UCBCares@ucb.com
Contact person for scientific queries

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