Chronic Allograft InjuryPhase 1/2NCT04335578
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
A Phase 1/2 study testing Zampilimab in people with Chronic Allograft Injury, run by UCB Biopharma SRL at 5 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Allograft Injury
- What is being tested?
- Zampilimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 21 Oct 2019to 4 May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
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
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).
- Conditions
- Chronic Allograft Injury
- Being tested
- Zampilimab, Placebo
- Keywords
- Chronic Allograft Injury, UCB7858, Kidney transplantation, CAI, zampilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZampilimabDrug
Also called UCB7858
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
PlaceboDrug
Also called PBO
Participants will receive matching placebo (PBO) at pre-specified time-points.
| Study group | Role | What they receive |
|---|---|---|
| Zampilimab Cohorts | Experimental | Participants will be randomized to receive zampilimab (UCB7858). Receives: Drug: Zampilimab |
| Placebo | Placebo comparator | Participants randomized to this arm will receive matching Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary outcomes (2)
Serum concentration of zampilimab
Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Measured: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Urine concentration of zampilimab
Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
Measured: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start21 Oct 2019
- Primary completion4 May 2022
- Study completion4 May 2022
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Allograft InjuryStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Principal investigator, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335578
- Sponsor's protocol ID
- CAI001
- Other IDs
- 2017-004807-31, 2017
- Status last verified
- Sep 2022
- First submitted
- 3 Apr 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Zhou X, Trinh-Minh T, Matei AE, Gyorfi AH, Hong X, Bergmann C, Schett G, Atkinson J, Bowcutt R, Patel J, Johnson TS, Distler JHW. Amelioration of Fibrotic Remodeling of Human 3-Dimensional Full-Thickness Skin by Transglutamase 2 Inhibition. Arthritis Rheumatol. 2023 Sep;75(9):1619-1627. doi: 10.1002/art.42518. Epub 2023 Jul 5.
PubMed 37057394
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04335578
- Acronym / sponsor ID
- CAI001
- Conditions
- Chronic Allograft Injury
- Keywords
- Chronic Allograft Injury, UCB7858, Kidney transplantation, CAI, zampilimab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zampilimab Cohorts | Experimental | Drug: ZampilimabParticipants will be randomized to receive zampilimab (UCB7858). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive matching Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZampilimabAlso: UCB7858Participants will receive zampilimab (UCB7858) at pre-specified time-points. | Drug | Zampilimab Cohorts |
| PlaceboAlso: PBOParticipants will receive matching placebo (PBO) at pre-specified time-points. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Serum concentration of zampilimab
Time frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Urine concentration of zampilimab
Time frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Results and safety
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 37057394Zhou X, Trinh-Minh T, Matei AE, Gyorfi AH, Hong X, Bergmann C, Schett G, Atkinson J, Bowcutt R, Patel J, Johnson TS, Distler JHW. Amelioration of Fibrotic Remodeling of Human 3-Dimensional Full-Thickness Skin by Transglutamase 2 Inhibition. Arthritis Rheumatol. 2023 Sep;75(9):1619-1627. doi: 10.1002/art.42518. Epub 2023 Jul 5.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares principal investigator
001 844 599 2273
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zampilimab in people with Chronic Allograft Injury, run by UCB Biopharma SRL at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Australia, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.