Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis

• Status: Not yet recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institutul Clinic Fundeni
• Treatments: Cyclophosphamide; Mycophenolic Acid; Rituximab

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