A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis

Conditions

Active Proliferative Lupus Nephritis

Brief summary

"CRR at Week 52, ie, meeting all of the following: - UPCR ≤ 0.5 mg/mg - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%"

Detailed description

"Sustained OCS reduction, ie, meeting all of the following: - OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Week 24 - Sustained OCS dose of ≤ 7.5 mg/day prednisone or equivalent from Week 24 through Week 52", "Time to sustained CRR, ie, meeting all of the following: - UPCR ≤ 0.5 mg/mg - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20% (ie, time from first study intervention dose to achieving CRR that is sustained from that time point through Week 52)", Cumulative UPCR as determined by the standardized AUC from baseline up to and including Week 52., CRR at Week 24 (see definition above), Time to renal event as defined as any of the following: 1) ESKD, 2) doubling of serum creatinine, 3) renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure, or 5) death - through Week 52., Time to renal-related event or death (see definition above) through Week 76

Related papers

No related papers found yet.

Interventions

DRUGSaphnelo 300 mg concentrate for solution for infusion

DRUGAnifrolumab Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
"CRR at Week 52, ie, meeting all of the following: - UPCR ≤ 0.5 mg/mg - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20%"	—

Secondary

Measure	Time frame
"Sustained OCS reduction, ie, meeting all of the following: - OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Week 24 - Sustained OCS dose of ≤ 7.5 mg/day prednisone or equivalent from Week 24 through Week 52", "Time to sustained CRR, ie, meeting all of the following: - UPCR ≤ 0.5 mg/mg - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20% (ie, time from first study intervention dose to achieving CRR that is sustained from that time point through Week 52)", Cumulative UPCR as determined by the standardized AUC from baseline up to and including Week 52., CRR at Week 24 (see definition above), Time to renal event as defined as any of the following: 1) ESKD, 2) doubling of serum creatinine, 3) renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure, or 5) death - through Week 52., Time to renal-related event or death (see definition above) through Week 76	—

Measure

Time frame

"Sustained OCS reduction, ie, meeting all of the following: - OCS dose of ≤ 7.5 mg/day prednisone or equivalent by Week 24 - Sustained OCS dose of ≤ 7.5 mg/day prednisone or equivalent from Week 24 through Week 52", "Time to sustained CRR, ie, meeting all of the following: - UPCR ≤ 0.5 mg/mg - eGFR ≥ 60 mL/min/1.73 m2 or no decrease from baseline of ≥ 20% (ie, time from first study intervention dose to achieving CRR that is sustained from that time point through Week 52)", Cumulative UPCR as determined by the standardized AUC from baseline up to and including Week 52., CRR at Week 24 (see definition above), Time to renal event as defined as any of the following: 1) ESKD, 2) doubling of serum creatinine, 3) renal worsening as evidenced by increased proteinuria and/or renal function impairment, or 4) renal disease treatment failure, or 5) death - through Week 52., Time to renal-related event or death (see definition above) through Week 76

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Countries

Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, Poland

Outcome results

None listed