Status:
RECRUITING
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Lead Sponsor:
Institutul Clinic Fundeni
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 r...
Detailed Description
After an initial screening phase during which a first kidney biopsy is performed, all patients that meet the inclusion criteria will be randomized to one of the treatment arms: * EUROLUPUS regimen: 3...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05207358
Start Date
March 2 2022
End Date
December 31 2028
Last Update
March 3 2022
Active Locations (1)
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1
Fundeni Clinical Institute
Bucharest, Romania, 022328