Minimal Change DiseasePhase 2NCT05441826
Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 study testing VB119 in people with Minimal Change Disease and Focal Segmental Glomerulosclerosis, run by Tenet Medicines at 1 site in United States.
Trial summary
Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Change Disease, Focal Segmental Glomerulosclerosis
- What is being tested?
- VB119
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2022to 12 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is ≥ 18 years of age at the time of informed consent;
- Kidney biopsy-proven diagnosis of primary MCD or primary FSGS within the past 10 years. Subjects with kidney biopsy-proven diagnosis of primary MCD or primary FSGS greater than 10 years and less than 20 years prior to Screening who meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor
- History of steroid-sensitive MCD or FSGS, defined as having achieved complete remission of proteinuria (reduction of proteinuria to <0.5 g/g UPCR) after use of corticosteroids;
- Has experienced meaningful proteinuria in the last 2 years prior to Screening, defined as UPCR >2.0 g/g, after attempted or completed tapering of steroids and/or CNIs that occurs within 6 months of the attempt or completion of tapering;
- Currently on prednisone regimen at time of Screening and anticipated to be tapered to a stable dose of prednisone of no more than 20 mg/day for at least 14 days prior to Day 1
- Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
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- Is willing and able to provide written informed consent prior to Screening;
- Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
- Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days (4 months) after the last administration of study drug.
- Male subjects must agree to abstain from sperm donation through 125 days (4 months) after administration of the last dose of study drug.
Who cannot join
- Has an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology Collaboration formula confirmed by the central laboratory;
- Has an absolute neutrophil count <1.5 x 10/L;
- Has a white blood cell count <3.0 x 10/L;
- Has secondary causes of MCD or FSGS (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
- Has a diagnosis or history of SLE (including non renal disease);
- Has type 1 or 2 diabetes mellitus;
- Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)
Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy.
- Being tested
- VB119
- Medical subject headings
- Nephrosis, Lipoid, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB119Drug
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.
| Study group | Role | What they receive |
|---|---|---|
| VB119 | Experimental | VB119 100 or 200mg IV doses administered 4 times Receives: Drug: VB119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in remission at End of Treatment
Efficacy
Measured: Day 274
Incidence of serious adverse events (SAEs)
Safety and Tolerability
Measured: through Day 420
Incidence of treatment-emergent adverse events (TEAEs)
Safety and Tolerability
Measured: through Day 420
Incidence of adverse events of special interest (AESIs)
Safety and Tolerability
Measured: through Day 420
Secondary outcomes (3)
Change in UPCR
Efficacy
Measured: Multiple timepoints from Day 1 to Day 337
Change in eGFR
Efficacy
Measured: Multiple timepoints from Screening to Day 337
Proportion of subjects that are recurrence-free
Efficacy
Measured: From Day 1 to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start3 May 2022
- Primary completion3 May 2023
- Study completion12 Oct 2023
Why it stopped: Sponsor change
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 Minimal Change DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenet Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keenan, Study chair, ValenzaBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441826
- Sponsor's protocol ID
- 119-02-02
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
PubMed 38724717
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)
- ClinicalTrials.gov ID
- NCT05441826
- Acronym / sponsor ID
- 119-02-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor change
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tenet MedicinesIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 1 Jul 2022 (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.
Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VB119 | Experimental | Drug: VB119VB119 100 or 200mg IV doses administered 4 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is ≥ 18 years of age at the time of informed consent;
- Kidney biopsy-proven diagnosis of primary MCD or primary FSGS within the past 10 years. Subjects with kidney biopsy-proven diagnosis of primary MCD or primary FSGS greater than 10 years and less than 20 years prior to Screening who meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor
- History of steroid-sensitive MCD or FSGS, defined as having achieved complete remission of proteinuria (reduction of proteinuria to <0.5 g/g UPCR) after use of corticosteroids;
- Has experienced meaningful proteinuria in the last 2 years prior to Screening, defined as UPCR >2.0 g/g, after attempted or completed tapering of steroids and/or CNIs that occurs within 6 months of the attempt or completion of tapering;
- Currently on prednisone regimen at time of Screening and anticipated to be tapered to a stable dose of prednisone of no more than 20 mg/day for at least 14 days prior to Day 1
Key exclusion criteria (7 listed)
- Has an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology Collaboration formula confirmed by the central laboratory;
- Has an absolute neutrophil count <1.5 x 10/L;
- Has a white blood cell count <3.0 x 10/L;
- Has secondary causes of MCD or FSGS (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
- Has a diagnosis or history of SLE (including non renal disease);
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 |
|---|---|---|
| VB119Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study. | Drug | VB119 |
Primary outcome
The proportion of subjects in remission at End of Treatment
Time frame: Day 274
Efficacy
Incidence of serious adverse events (SAEs)
Time frame: through Day 420
Safety and Tolerability
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: through Day 420
Safety and Tolerability
Incidence of adverse events of special interest (AESIs)
Time frame: through Day 420
Safety and Tolerability
3 secondary outcomes
Change in UPCR
Time frame: Multiple timepoints from Day 1 to Day 337
Change in eGFR
Time frame: Multiple timepoints from Screening to Day 337
Proportion of subjects that are recurrence-free
Time frame: From Day 1 to Day 337
Results and safety
The study was stopped early (reason given: Sponsor change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 38724717Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
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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.
Keenan study chair
ValenzaBio, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB119 in people with Minimal Change Disease and Focal Segmental Glomerulosclerosis, run by Tenet Medicines at 1 site 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 10 inclusion and 7 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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 stopped early (reason given: Sponsor change). 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?
The proportion of subjects in remission at End of Treatment (time frame: Day 274). The study lists 4 primary outcomes in all. 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 NCT05441826, 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 22 Apr 2024.