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
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.
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 →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.
Exclusion Criteria:
VB119 100 or 200mg IV doses administered 4 times
Drug: VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.
The proportion of subjects in remission at End of Treatment
Efficacy
Time frame: Day 274
Incidence of serious adverse events (SAEs)
Safety and Tolerability
Time frame: through Day 420
Incidence of treatment-emergent adverse events (TEAEs)
Safety and Tolerability
Time frame: through Day 420
Incidence of adverse events of special interest (AESIs)
Safety and Tolerability
Time frame: through Day 420
Change in UPCR
Efficacy
Time frame: Multiple timepoints from Day 1 to Day 337
Change in eGFR
Efficacy
Time frame: Multiple timepoints from Screening to Day 337
Proportion of subjects that are recurrence-free
Efficacy
Time frame: From Day 1 to Day 337
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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Glomerulosclerosis, Focal Segmental→
Tenet Medicines