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
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, RomaniaTaking 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?
Trial 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.