Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Christopher Carlos (ucsf)
Headshot of Christopher Carlos
Christopher Carlos

Description

Summary

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

Official Title

An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.

Details

This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first year of treatment (Group A) or at the end of the second year of treatment (Group B).

The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).

Keywords

Immunoglobulin A Nephropathy (IgAN), zigakibart, FUB523, anit-APRIL, SHIFT, IgA nephropathy, IgAN, proteinuria, kidney, biopsy, adults, IGA Glomerulonephritis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening
  • eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening
  • Persistent proteinuria, defined as either
    • Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or
    • IgAN diagnosis <6 months prior to Screening with Total Urine Protein >1.5 g/day or UPCR >1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis
  • Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening

You CAN'T join if...

  • Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder
  • Total IgG <6.0 g/L at screening
  • Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections
  • An average systolic blood pressure >150 mmHg or average diastolic blood pressure >90 mmHg based on three measurements at Screening
  • Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening
  • Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening
  • Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for >3 consecutive months prior to screening
  • Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening

Other protocol-defined inclusion/exclusion criteria may apply.

Locations

  • UC San Francisco Medical Center accepting new patients
    San Francisco California 94143-0348 United States
  • Colorado Kidney Care Nephrology accepting new patients
    Denver Colorado 80230 United States

Lead Scientist at University of California Health

  • Christopher Carlos (ucsf)
    Dr. Christopher Carlos is a board-certified nephrologist who cares for patients with a wide range of kidney conditions in both the hospital and clinic. His outpatient practice focuses on acute kidney injury, chronic kidney disease, end-stage kidney disease, hypertension, electrolyte disorders, and glomerular diseases.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT07146906
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated