LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4 interventional study evaluating the safety and efficacy of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis. Participants will also receive a mycophenolate mofetil or mycophenolic acid analog and corticosteroids as part of the regimen. The aim is to induce a rapid renal response while monitoring safety in a real-world setting. Eligible patients have biopsy-confirmed LN, specific proteinuria and kidney function criteria, and are on or willing to start the accompanying biologic and MPAA therapy. Primary assessments include renal response rates and adverse events over the treatment period.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Adults 18-75 years old
* Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V)
* Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and \<5.0 g/g from a first morning void (FMV) urine sample
* Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2
* Concomitant biologic:

  * Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day 1.
  * Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.
* Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1
* Willing to take corticosteroids, either by continuing current corticosteroids (prednisone \[or equivalent\]) or by initiating on or before Day 1

Key Exclusion Criteria:

* Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range
* Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening
* Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone \[or equivalent\]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:

  * Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)
  * Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)
  * T cell costimulation modulator (eg, abatacept)
  * Intravenous immunoglobulin (IVIg)
  * Janus kinase (JAK) inhibitors (eg, upadacitinib)
* Pregnant, breastfeeding or intending to become pregnant during the Study

Where it's running

• Purushotham & Akther Kotha MD, Inc.
  La Mesa, California, United States Recruiting
• Valerius Medical Group & Research Center of Greater Long Beach, Inc.
  Los Alamitos, California, United States Recruiting
• Western Nephrology & Metabolic Bone Disease, PC
  Arvada, Colorado, United States Recruiting
• Swati Shah MD Rheumatology, LLC
  Jacksonville, Florida, United States Recruiting
• Vida Clinical Research
  Kissimmee, Florida, United States Recruiting
• Life Clinical Trials
  Margate, Florida, United States Recruiting

Study contacts

• Study coordinator: Aurinia Clinical Trials Information
• Email: clinicaltrials@auriniapharma.com
• Phone: 833-606-5975

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining belimumab and voclosporin for proliferative lupus kidney disease

  This trial will test whether giving belimumab and voclosporin together with background mycophenolate helps people with proliferative lupus nephritis reach complete kidney remission and lets doctors stop mycophenolate sooner.

  Recruiting at 7 sites Phase 4 NephroNet, Inc. · Glendale, Arizona and 6 other locations · NCT07225387

• Assessing the effectiveness of belimumab for lupus nephritis treatment

  This study is testing how well belimumab works for adults with active lupus nephritis to see if it helps protect their kidney function over time.

  Recruiting at 7 sites GlaxoSmithKline · Baltimore, Maryland and 6 other locations · NCT06527872

• Evaluating Obinutuzumab for Lupus Nephritis in Adolescents

  This study is testing if a medication called obinutuzumab can help teenagers with lupus nephritis feel better and improve their kidney health.

  Recruiting at 33 sites Phase 2 Hoffmann-La Roche · Loma Linda, California and 43 other locations · NCT05039619

• Comparing treatments for lupus nephritis without added oral steroids

  This study is testing whether a treatment for lupus nephritis using obinutuzumab and mycophenolate mofetil without steroids can work just as well as a treatment that includes steroids.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Paris · NCT04702256

• Effects of anifrolumab on arterial inflammation in SLE patients

  This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.

  Recruiting University of Cambridge · Cambridge, Cambridgeshire · NCT07913919

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

  This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.

  Recruiting Phase 1/2 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Badalona, Barcelona and 7 other locations · NCT07799116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.