A Study to Assess the Effects of Zigakibart on IgA Nephropathy. (SHIFT)

Novartis

Status and phase

Not yet enrolling

Phase 2

Conditions

Immunoglobulin A Nephropathy (IgAN)

Treatments

Biological: zigakibart

Study type

Interventional

Funder types

Industry

Identifiers

NCT07146906

2024-519699-24 (Other Identifier)

CFUB523A12201

U1111-1323-5075 (Other Identifier)

Details and patient eligibility

About

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

Full description

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).

Enrollment

32 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Untreated hypertension or uncontrolled hypertension despite treatment (i.e., resistant hypertension)
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.