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TerminatedNCT05441826Updated Apr 22, 2024

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 interventional study of VB119 in Minimal Change Disease and Focal Segmental Glomerulosclerosis, sponsored by Tenet Medicines. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Tenet Medicines · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor change

From the registry’s dates

  • Primary completion was May 2023, 3 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Minimal Change Disease
  • Focal Segmental Glomerulosclerosis
03

In context

Glomerulosclerosis, Focal Segmental

98 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 31 are open to participants now.

This study's enrollment of 1 is below the median of 32 across 69 interventional studies indexed under Glomerulosclerosis, Focal Segmental.

Browse Glomerulosclerosis, Focal Segmental studies →

Lead sponsor

Tenet Medicines is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Is ≥ 18 years of age at the time of informed consent;
  2. 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
  3. 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;
  4. 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;
  5. 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
  6. Has systolic blood pressure (BP) \<160 mmHg or diastolic BP \<100 mmHg after 5 minutes of rest at Screening;
  7. Is willing and able to provide written informed consent prior to Screening;
  8. 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;
  9. 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.
  10. Male subjects must agree to abstain from sperm donation through 125 days (4 months) after administration of the last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Has an absolute neutrophil count \<1.5 x 10/L;
  3. Has a white blood cell count \<3.0 x 10/L;
  4. 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);
  5. Has a diagnosis or history of SLE (including non renal disease);
  6. Has type 1 or 2 diabetes mellitus;
  7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infection.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    VB119

    VB119 100 or 200mg IV doses administered 4 times

    Drug: VB119

Interventions

  • DrugVB119

    Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.

06

What researchers measure

Primary outcomes

  1. The proportion of subjects in remission at End of Treatment

    Efficacy

    Time frame: Day 274

  2. Incidence of serious adverse events (SAEs)

    Safety and Tolerability

    Time frame: through Day 420

  3. Incidence of treatment-emergent adverse events (TEAEs)

    Safety and Tolerability

    Time frame: through Day 420

  4. Incidence of adverse events of special interest (AESIs)

    Safety and Tolerability

    Time frame: through Day 420

Secondary outcomes

  1. Change in UPCR

    Efficacy

    Time frame: Multiple timepoints from Day 1 to Day 337

  2. Change in eGFR

    Efficacy

    Time frame: Multiple timepoints from Screening to Day 337

  3. Proportion of subjects that are recurrence-free

    Efficacy

    Time frame: From Day 1 to Day 337

07

Study locations

1 site
  • Clinical Research Site
    Albany, New York 12208, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05441826
Lead sponsor
Tenet Medicines
Responsible party
Sponsor
First posted
Jul 1, 2022
Start date
May 3, 2022
Primary completion
May 3, 2023
Completion
Oct 12, 2023
Last update
Apr 22, 2024

Study contacts

Keenan
study chair · ValenzaBio, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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