A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients with Primary IgA Nephropathy at High Risk of Progression

Conditions

Primary Immunoglobulin A (IgA) Nephropathy

Brief summary

Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection

Detailed description

Estimated eGFR slope at Week 105 from baseline. eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, Time to the composite kidney failure endpoint, defined as receipt of kidney transplantation, need for kidney replacement therapy, a sustained decline in eGFR of ≥ 30% from baseline, or a sustained eGFR < 15 mL/min/1.73m2 over at least 4 weeks (both eGFR criteria requiretwo consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN, Change in fatigue at Week 105 compared with baseline, as assessed through the use of the Functional Assessment of Chronic Illness Therapy−Fatigue Scale, Incidence and severity of treatment-emergent adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 grading scale, Plasma concentrations of RO7434656 conjugated and/or unconjugated equivalent at specified timepoints

Related papers

No related papers found yet.

Interventions

DRUGPNEUMOCOCCUS

DRUGPURIFIED POLYSACCHARIDES ANTIGEN

DRUGASO FACTOR B PLACEBO

DRUGASO FACTOR B

DRUG-

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection	—

Secondary

Measure	Time frame
Estimated eGFR slope at Week 105 from baseline. eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, Time to the composite kidney failure endpoint, defined as receipt of kidney transplantation, need for kidney replacement therapy, a sustained decline in eGFR of ≥ 30% from baseline, or a sustained eGFR < 15 mL/min/1.73m2 over at least 4 weeks (both eGFR criteria requiretwo consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN, Change in fatigue at Week 105 compared with baseline, as assessed through the use of the Functional Assessment of Chronic Illness Therapy−Fatigue Scale, Incidence and severity of treatment-emergent adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 grading scale, P	—

Measure

Time frame

Estimated eGFR slope at Week 105 from baseline. eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, Time to the composite kidney failure endpoint, defined as receipt of kidney transplantation, need for kidney replacement therapy, a sustained decline in eGFR of ≥ 30% from baseline, or a sustained eGFR < 15 mL/min/1.73m2 over at least 4 weeks (both eGFR criteria requiretwo consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN, Change in fatigue at Week 105 compared with baseline, as assessed through the use of the Functional Assessment of Chronic Illness Therapy−Fatigue Scale, Incidence and severity of treatment-emergent adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 grading scale, P

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Countries

Czechia, France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed