Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Recruiting · NCT05207358 · Interventional (participants receive a specific treatment) · Lead sponsor: Institutul Clinic Fundeni
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Fundeni Clinical Institute - Bucharest, Romania