Testing a lower-steroid regimen for lupus kidney inflammation
Compares a lower-steroid treatment with standard therapy in adults with lupus nephritis.
Plain-language title generated from the registry record
Registry title: Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Key facts
- Where
- Bucharest, RomaniaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active proliferative lupus nephritis (kidney inflammation caused by lupus), confirmed by kidney biopsy. It compares a treatment that uses less glucocorticoid with standard therapy.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Systemic lupus erythematosus with proliferative lupus nephritis class III, IV +/- V, confirmed by kidney biopsy. Kidney function (eGFR by CKD-EPI) above 30 ml / min / 1.73 sqm, or above 15 but below 30 with chronicity index (NIH score) below 6.
- Earlier treatment
- Cannot have had more than 2 g of intravenous Methylprednisolone in the last 4 weeks, biological therapy in the last 3 months, or intravenous immunoglobulins / plasmapheresis in the last 6 months.
Main reasons for not taking part
- Life-threatening complications (for example cerebritis)
- Pregnancy or breastfeeding
- Active infection
- History of neoplasia
- Other conditions that need systemic corticosteroid treatment
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05207358, who can take part
Where in Romania
- Fundeni Clinical InstituteBucharest, RomaniaContact: Bogdan Obrisca, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institutul Clinic Fundeni
- Trial code
- NCT05207358
- Record updated
- 3 March 2022
- Original description
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.Read full original descriptionShow less
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study
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.
Inclusion: 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: 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; Comorbidities requiring systemic corticosteroid therapy; The presence of an active infection; History of neoplasia; 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; Use of intravenous immunoglobulins / plasmapheresis in the last 6 months; Non-adhesion.