Reducing glucocorticoid use in patients with lupus nephritis

Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study

This study is testing two different treatment plans for people with lupus nephritis to see which one helps reduce the use of steroids while still effectively managing their condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Institutul Clinic Fundeni (Academic / other)
• Drugs / interventions: Rituximab, Cyclophosphamide
• Locations: 1 site (Bucharest)
• Trial ID: NCT05207358 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with proliferative lupus nephritis.

Not a fit: Patients with life-threatening complications or severe renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer treatment options for patients with lupus nephritis by reducing glucocorticoid-related side effects.

How similar studies have performed: Other studies have shown promise in reducing glucocorticoid use in similar patient populations, indicating that this approach may be viable.

Eligibility criteria

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 this trial is running

Bucharest

• Fundeni Clinical Institute — Bucharest, Romania (Recruiting)

Study contacts

• Principal investigator: Gener Ismail, MD, PhD — Institutul Clinic Fundeni
• Study coordinator: Bogdan Obrisca, MD, PhD

Conditions Lupus Nephritis; immunosuppression; glucocorticoids; eurolupus; rituxilup; induction therapy