🏛️ Verified NIH Record • Updated 2026-07-30

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis (NCT05138133)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: Research Site — Glendale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
  • Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
  • Evidence of hepatitis C or active hepatitis B.
  • Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
  • Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
  • Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
  • Known intolerance to ≤ 1.0 g/day of MMF.
  • Any history of severe COVID-19 infection.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (164 Sites)

  • Research Site — Glendale, Arizona
  • Research Site — La Palma, California
  • Research Site — Los Angeles, California
  • Research Site — Upland, California
  • Research Site — Plantation, Florida
  • Research Site — Atlanta, Georgia
  • Research Site — Louisville, Kentucky
  • Research Site — Summit, New Jersey
  • Research Site — Manhasset, New York
  • Research Site — New York, New York
  • Research Site — Winston-Salem, North Carolina
  • Research Site — Middleburg Heights, Ohio
  • Research Site — Colleyville, Texas
  • Research Site — Edinburg, Texas
  • Research Site — El Paso, Texas
  • Research Site — Houston, Texas
  • Research Site — CABA,
  • Research Site — Ciudad de Buenos Aires,
  • Research Site — La Plata,
  • Research Site — Rosario,
  • Research Site — San Juan,
  • Research Site — Brussels,
  • Research Site — Leuven,
  • Research Site — Liège,
  • Research Site — Belo Horizonte,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗