Health TrialsbyHealthPanel

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

ConditionImmunoglobulin A Nephropathy (IgAN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • zigakibart

    Biological/Vaccine

    zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: zigakibartExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in mesangial IgA deposition

Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining

Time frame
Baseline to Week 53 or 105

Secondary outcomes

1

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence of AEs and SAEs , including changes in vital signs, injection site reactions, laboratory results and Immunoglobulin responses to vaccination qualifying and reported as AEs

Time frame
Day 1 to Week 118
2

Change in MEST-C score

Change in MEST-C, a histologic scoring system used to assess disease prognosis in patients with IgA nephropathy, which includes the components mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental glomerulosclerosis (S), and tubular atrophy/interstitial fibrosis (T), crescents (C). All five components are scored by categorical values as listed below, where a higher score indicates involvement or a relatively greater degree of involvement (i.e., more severe pathology). 1. Mesangial hypercellularity * M0 (present in ≤50% of glomeruli) * M1 (present in \>50% of glomeruli) 2. Endocapillary hypercellularity * E0 (Absent) * E1 (Present) 3. Segmental glomerulosclerosis (more than four mesangial cells) * S0 (Absent) * S1 (Present) 4. Tubular atrophy/interstitial fibrosis * T0 (0-25% of cortical area) * T1 (26-50% of cortical area) * T2 (\>50% of cortical area) 5. Cellular or fibrocellular crescents * C0 (No crescents) * C1 (\>25% of glomeruli) * C2 (≥25% of glomeruli)

Time frame
Baseline to Week 53 or 105
3

Change in CD68+ cells in glomeruli and tubulo-interstitial compartment

Change in CD68+ cells, which are markers of inflammation

Time frame
Baseline to Week 53 or 105
4

Change in complement component C3c

Change in C3c, which is a marker of complement (part of the immune system) activation

Time frame
Baseline to Week 53 or 105

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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