An open-label, uncontrolled, 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

Conditions

IgA nephropathy

Brief summary

Change in the level of IgA deposition in kidney tissue after 1 or 2 years of zigakibart treatment, compared to before treatment.

Detailed description

Clinical/laboratory assessments and adverse events., Impact on immune response to vaccination, during the period of 6 to 23 months after the first treatment., Kidney biopsy measures: changes in MEST- C score (an established measure of IgAN severity) and CD68 and C3c (inflammation markers), after 1 or 2 years of zigakibart treatment compared to before treatment., Kidney function tests: urine protein and blood presence and estimated glomerular filtration rate (a blood test assessing kidney’s filtering function), at multiple timepoints during the 2- year zigakibart treatment compared to before treatment., IgAN markers in blood: Immunoglobulin levels (IgA, IgM, IgG) at multiple timepoints during the 2-year zigakibart treatment compared to before treatment., Zigakibart concentrations in blood at multiple timepoints during the 2-year treatment., Presence of antibodies against zigakibart in blood before and at multiple timepoints during the 2-year zigakibart treatment.

Related papers

No related papers found yet.

Interventions

DRUGBion 1301/FUB523

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in the level of IgA deposition in kidney tissue after 1 or 2 years of zigakibart treatment, compared to before treatment.	—

Secondary

Measure	Time frame
Clinical/laboratory assessments and adverse events., Impact on immune response to vaccination, during the period of 6 to 23 months after the first treatment., Kidney biopsy measures: changes in MEST- C score (an established measure of IgAN severity) and CD68 and C3c (inflammation markers), after 1 or 2 years of zigakibart treatment compared to before treatment., Kidney function tests: urine protein and blood presence and estimated glomerular filtration rate (a blood test assessing kidney’s filtering function), at multiple timepoints during the 2- year zigakibart treatment compared to before treatment., IgAN markers in blood: Immunoglobulin levels (IgA, IgM, IgG) at multiple timepoints during the 2-year zigakibart treatment compared to before treatment., Zigakibart concentrations in blood at multiple timepoints during the 2-year treatment., Presence of antibodies against zigakibart in blood before and at multiple timepoints during the 2-year zigakibart treatment.	—

Measure

Time frame

Clinical/laboratory assessments and adverse events., Impact on immune response to vaccination, during the period of 6 to 23 months after the first treatment., Kidney biopsy measures: changes in MEST- C score (an established measure of IgAN severity) and CD68 and C3c (inflammation markers), after 1 or 2 years of zigakibart treatment compared to before treatment., Kidney function tests: urine protein and blood presence and estimated glomerular filtration rate (a blood test assessing kidney’s filtering function), at multiple timepoints during the 2- year zigakibart treatment compared to before treatment., IgAN markers in blood: Immunoglobulin levels (IgA, IgM, IgG) at multiple timepoints during the 2-year zigakibart treatment compared to before treatment., Zigakibart concentrations in blood at multiple timepoints during the 2-year treatment., Presence of antibodies against zigakibart in blood before and at multiple timepoints during the 2-year zigakibart treatment.

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Outcome results

None listed