Principal Investigator: Neil Kramer, MD, MACR, FACP – Atlantic Health System

Hypothesis / Research Question

To see if addition of anifrolumab to standard of care (mycophenolate mofetil) for class III or IV (with or without concomitant class V) lupus nephritis improves renal response.

Brief Description

Patients with renal biopsy within the 6 months prior to screening showing class III, IV without or without class V lupus nephritis and have a UPCR > 1mg/mg will be randomized 1:1 to receive monthly anifrolumab or placebo, added to MMF 1000 mg BID and followed for 76 weeks. There will also be an open label long term extension study.

Key Criteria

• Inclusion: 1) Active proliferative LN Class III or IV either with or without the presence of Class V  2) Renal biopsy obtained within 6 months prior to signing the informed consent or during screening 3) Urine protein to creatinine ratio > 1mg/mg (113.17 mg/mmole) 4) eGFR > 35 mL/min/1.73 m2 5) Fulfills updated 2019 EULAR/ACR SLE classification criteria 6) No signs of active TB                             
• Exclusion: 1) Pure class V lupus nephritis 2) Primary immunodeficiency, splenectomy or HIV 3) Hepatitis C or active hepatitis B 4) Any history of cancer except cured skin nonmelanoma cancer or cervical cancer in situ. 5) Receipt within the prior 6 months of cyclophosphamide, >2.5 g/day MMF or tacrolimus >4 mg/day for more than 8 weeks.

Contact

  neil.kramer@atlantichealth.org
 (908) 598-7940

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