Highly Sensitized Patients on Waiting List for Kidney TransplantationPhase 2NCT04174677
Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
A Phase 2 study testing Inebilizumab, VIB4920 and Inebilzumab+VIB4920 in people with Highly Sensitized Patients on Waiting List for Kidney Transplantation, run by Amgen at 2 sites in United States.
Trial summary
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Highly Sensitized Patients on Waiting List for Kidney Transplantation
- What is being tested?
- Inebilizumab, VIB4920 and Inebilzumab+VIB4920
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2019to Apr 2022
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with ESRD who are maintained on hemodialysis.
- Subjects awaiting first or second kidney transplantation from a deceased donor.
- Subjects with cPRA 98 100% at Screening Visit 1, calculated using antibodies with titer ≥ 1:16 and/or MFI value ≥ 1400, verified by the central laboratory.
- Subjects with stable anti-HLA antibody titers (a difference of < 2 titers versus the average titer of antibodies compared to the screening sample) based on 2 legacy samples drawn within 6 to 12 months prior to Screening Visit 1, verified by the central laboratory.
Who cannot join
- Subjects awaiting kidney transplantation from a living donor.
- Subjects who have previously undergone desensitization with plasmapheresis/plasma exchange, IVIG, rituximab, imlifidase, tocilizumab or a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib, others) within 12 months prior to randomization.
- Candidates for a second kidney allograft if the first allograft was lost within 12 months prior to screening.
- Subjects who have experienced a sensitizing event (eg, pregnancy, blood transfusion) within 6 months prior to screening.
- Recipients of a prior non-kidney organ transplant or stem cell transplant.
- Subjects treated with systemic immunosuppressive drug therapy for more than a total of 2 weeks within 12 months prior to ICF signature (treatment with corticosteroids < 10 mg/day PO prednisone or equivalent for less than a total of 2 weeks during the 4 weeks prior to screening is allowed).
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- Subjects who have undergone lympho-depleting therapy (eg, Thymoglobulin, alemtuzumab) within 12 months prior to randomization.
- Subjects with known immunodeficiency.
- Subjects with known platelet disorders, or history of arterial or venous thromboembolism unrelated to hemodialysis access procedures.
- Subjects with history of prothrombotic status (including but not limited to congenital or inherited deficiency of antithrombin III, protein C, protein S), or confirmed diagnosis of catastrophic antiphospholipid syndrome.
- Subjects requiring treatment with antithrombotic drugs (clopidogrel, prasugrel, warfarin, others). Low-dose aspirin treatment (up to 325 mg/day) is allowed.
- Major surgery within 12 weeks prior to screening.
- Receipt of live (attenuated) vaccine within the 4 weeks prior to screening.
- Previous treatment with anti-CD40L agents.
- Use of B-cell depleting therapy (eg, inebilizumab, rituximab, ocrelizumab, obinutuzumab), non-depleting B-cell directed therapy (eg, belimumab), an anti-CD40 agent, belatacept, or abatacept within 1 year prior to enrollment.
- Use of anti-interleukin (IL)-6 mAbs (eg, tocilizumab, clazakizumab), C1 esterase inhibitors, or complement inhibitors (eg, eculizumab) or imlifidase within 12 months prior to enrollment.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half lives of enrollment, whichever is longer.
- Subjects who have had more than one episode of severe infection requiring parenteral antimicrobial treatment within 12 months prior to screening.
- Subjects with a history of opportunistic infection within 12 months prior to screening (except for PO candidiasis, vaginal candidiasis, and cutaneous fungal infections).
- Subjects who have had more than one episode of herpes zoster within 12 months prior to screening.
- Subjects with uncontrolled diabetes mellitus (hemoglobin A1c ≥ 8.0% at screening).
- Subjects who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- Regarding hepatitis B, positive test for chronic hepatitis B infection at screening, defined as either (1) positive hepatitis B surface antigen (HBsAg) or (2) a positive hepatitis B core antibody (anti-HBcAb)
- History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless previously treated for latent TB. Subjects with an indeterminate QuantiFERON®-TB Gold test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
- History of cancer, except as follows:
- In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; or
- Cutaneous basal cell carcinoma treated with apparent success with curative therapy.
- Any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder that could impact the evaluation of safety and efficacy assessments or affect the subject's ability to participate in the study or the subject's safety.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennsylvania Reserach Site
Bethlehem, Pennsylvania, 18017
Reserach Site California
San Diego, California, 92123
About this study
Official title: A Phase 2 Open-label, Prospective, Randomized Study of Inebilizumab, VIB4920, or the Combination to Evaluate Safety and Tolerability in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation. Eligible subjects will be randomized to one of three treatment arms, administered the investigational products as an intervention and subsequently followed for safety.
Read the detailed description
Study acquired from Horizon in 2024.
- Being tested
- Inebilizumab, VIB4920, Inebilzumab+VIB4920
- Keywords
- cPRA, HLA antibodies, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InebilizumabDrug
Infusion of Inebilizumab
VIB4920Drug
Infusion of VIB4920
Inebilzumab+VIB4920Drug
Infusion of Inebilizumab and VIB4920
| Study group | Role | What they receive |
|---|---|---|
| Inebilzumab Treatment | Experimental | Infusion of Inebilizumab Receives: Drug: Inebilizumab |
| VIB4920 Treatment | Experimental | Infusion of VIB4920 Receives: Drug: VIB4920 |
| Inebilzumab+VIB4920 Treatment | Experimental | Infusion of Inebilizumab and VIB4920 Receives: Drug: Inebilzumab+VIB4920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with safety events (treatment-emergent adverse events, treatment-emergent serious adverse events, or treatment-emergent adverse events of special interest) during the course of the study
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Anti-drug antibodies (ADA) of inebilizumab and VIB4920
The ADA incidence rate will be summarized, where the incidence is the proportion of the subjects with ADA positive post-baseline only or boosted their pre existing ADA during the study period.
Measured: Through study completion, an average of 1 year
Maximum observed concentration of inebilizumab and VIB4920
Pharmacokinetic profile
Measured: Treatment phase of study (Day 1 of treatment to Day 197)
Area under the concentration-time curve of inebilizumab and VIB4920
Pharmacokinetic profile
Measured: Treatment phase of study (Day 1 of treatment to Day 197)
Total systemic clearance of inebilizumab and VIB4920
Pharmacokinetic profile
Measured: Treatment phase of study (Day 1 of treatment to Day 197)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start27 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: Stopped due to no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Highly Sensitized Patients on Waiting List for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174677
- Sponsor's protocol ID
- VIB0551.P2.S1
- Status last verified
- Jun 2024
- First submitted
- 5 Nov 2019
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Prospective, Randomized Study of Inebilizumab, VIB4920, or the Combination to Evaluate Safety and Tolerability in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor
- ClinicalTrials.gov ID
- NCT04174677
- Acronym / sponsor ID
- VIB0551.P2.S1
- Keywords
- cPRA, HLA antibodies, kidney transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped due to no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 22 Nov 2019 (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.
Viela Bio is conducting an open-label, randomized study of inebilizumab, VIB4920, or the combination as part of a multi-center study in highly sensitized patients on the deceased donor waiting list for kidney transplantation. Eligible subjects will be randomized to one of three treatment arms, administered the investigational products as an intervention and subsequently followed for safety.
Detailed description
Study acquired from Horizon in 2024.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inebilzumab Treatment | Experimental | Drug: InebilizumabInfusion of Inebilizumab |
| VIB4920 Treatment | Experimental | Drug: VIB4920Infusion of VIB4920 |
| Inebilzumab+VIB4920 Treatment | Experimental | Drug: Inebilzumab+VIB4920Infusion of Inebilizumab and VIB4920 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with ESRD who are maintained on hemodialysis.
- Subjects awaiting first or second kidney transplantation from a deceased donor.
- Subjects with cPRA 98 100% at Screening Visit 1, calculated using antibodies with titer ≥ 1:16 and/or MFI value ≥ 1400, verified by the central laboratory.
- Subjects with stable anti-HLA antibody titers (a difference of < 2 titers versus the average titer of antibodies compared to the screening sample) based on 2 legacy samples drawn within 6 to 12 months prior to Screening Visit 1, verified by the central laboratory.
Key exclusion criteria (28 listed)
- Subjects awaiting kidney transplantation from a living donor.
- Subjects who have previously undergone desensitization with plasmapheresis/plasma exchange, IVIG, rituximab, imlifidase, tocilizumab or a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib, others) within 12 months prior to randomization.
- Candidates for a second kidney allograft if the first allograft was lost within 12 months prior to screening.
- Subjects who have experienced a sensitizing event (eg, pregnancy, blood transfusion) within 6 months prior to screening.
- Recipients of a prior non-kidney organ transplant or stem cell transplant.
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 |
|---|---|---|
| InebilizumabInfusion of Inebilizumab | Drug | Inebilzumab Treatment |
| VIB4920Infusion of VIB4920 | Drug | VIB4920 Treatment |
| Inebilzumab+VIB4920Infusion of Inebilizumab and VIB4920 | Drug | Inebilzumab+VIB4920 Treatment |
Primary outcome
Number of subjects with safety events (treatment-emergent adverse events, treatment-emergent serious adverse events, or treatment-emergent adverse events of special interest) during the course of the study
Time frame: Through study completion, an average of 1 year
4 secondary outcomes
Anti-drug antibodies (ADA) of inebilizumab and VIB4920
Time frame: Through study completion, an average of 1 year
Maximum observed concentration of inebilizumab and VIB4920
Time frame: Treatment phase of study (Day 1 of treatment to Day 197)
Area under the concentration-time curve of inebilizumab and VIB4920
Time frame: Treatment phase of study (Day 1 of treatment to Day 197)
Total systemic clearance of inebilizumab and VIB4920
Time frame: Treatment phase of study (Day 1 of treatment to Day 197)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inebilizumab, VIB4920 and Inebilzumab+VIB4920 in people with Highly Sensitized Patients on Waiting List for Kidney Transplantation, run by Amgen at 2 sites in United States.
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 4 inclusion and 28 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: withdrawn, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 withdrawn before enrolling participants, so there are no results.
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?
Number of subjects with safety events (treatment-emergent adverse events, treatment-emergent serious adverse events, or treatment-emergent adverse events of special interest) during the course of the study (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2024.