Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis During the Induction of Remission Period-EUROLUPUS vs. RITUXILUP Regimen: A Randomized Study
Institutul Clinic Fundeni
30 participants
Mar 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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
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Interventions
2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15.
Patients will receive Mycophenolate Mofetil, initially 500 mg twice daily, titrated to a maximum of 1.5 g twice daily, depending on leukocyte count and digestive tolerance, which will be maintained 24 months.
All patients will receive Cyclophosphamide intravenously starting day 1, 6 pulses at a fixed dose of 500 mg given at 2 weeks. After 3 months, Azathioprine (2 mg / kg / day) is initiated 2 weeks after the last administration of Cyclophosphamide and maintained for the next 21 months.
3 daily pulses of 750 mg of intravenous Methylprednisolone, followed by oral corticosteroid therapy starting with a dose of 0.5 mg / kg / day for 4 weeks, then decreased by 2.5 mg of Prednisolone / day each 2 weeks. A low dose of glucocorticoid (5-7.5 mg / day) is maintained until 24 months after enrollment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05207358