Reducing glucocorticoid use in patients with 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 study evaluates a new treatment approach for patients with proliferative lupus nephritis by comparing two regimens that minimize glucocorticoid exposure during remission induction. Participants will be randomized to receive either the EUROLUPUS regimen, which involves a combination of intravenous Methylprednisolone and Cyclophosphamide followed by Azathioprine, or the RITUXILUP regimen, which includes Rituximab and Mycophenolate Mofetil. The efficacy of these regimens will be assessed through clinical and histological remission, with a second kidney biopsy performed six months after treatment initiation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age of the patient between 18 and 80 years,
* Patients diagnosed with systemic lupus erythematosus according to ACR 1997 or SLICC-2012 criteria
* Diagnosis of proliferative lupus nephritis class III, IV +/- V (confirmed by renal biopsy and classified according to ISN / RPS);
* Estimated glomerular filtration rate by CKD-EPI\> 30 ml / min / 1.73 sqm
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm but\> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score) \<6
* Absence of contraindications to the use of Methylprednisolone, Mycophenolate mofetil, oral corticosteroids or Rituximab
* Ability to provide informed consent

Exclusion Criteria:

* The patient's age under 18 years
* Patients with life-threatening complications (e.g. Cerebritis)
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm but\> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score)\> 6
* Presence of pregnancy / lactation
* Patients who have received more than 2 g of Methylprednisolone intravenously in the last 4 weeks
* Use in the last 3 months of biological therapy
* Use of intravenous immunoglobulins / plasmapheresis in the last 6 months
* The presence of an active infection
* History of neoplasia
* Comorbidities requiring systemic corticosteroid therapy
* Non-adhesion

Where it's running

• Fundeni Clinical Institute
  Bucharest, Romania Recruiting

Study contacts

• Principal investigator: Gener Ismail, MD, PhD — Institutul Clinic Fundeni
• Study coordinator: Bogdan Obrisca, MD, PhD
• Email: obriscabogdan@yahoo.com
• Phone: 0040721256797

Similar studies

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

• 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

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Biomarker tests in adults with lupus to see how kidney disease changes over time

  Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07666711

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

  This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.

  Recruiting at 27 sites Phase 4 Aurinia Pharmaceuticals Inc. · La Mesa, California and 26 other locations · NCT07611214

• Mosunetuzumab for people with systemic lupus erythematosus

  This study tests mosunetuzumab in people with systemic lupus erythematosus, with or without active lupus nephritis.

  Recruiting at 24 sites Phase 2 Hoffmann-La Roche · CABA, Buenos Aires and 23 other locations · NCT07598396

• FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN

  This trial tests whether FT819, a donor-derived CAR T cell therapy, can help people with difficult-to-treat lupus nephritis who have not responded to other medicines.

  Recruiting at 12 sites Phase 2 Fate Therapeutics · Beverly Hills, California and 11 other locations · NCT07570862

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.