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Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
RECRUITINGPhase 4Sponsored by Institutul Clinic Fundeni
Actively Recruiting
PhasePhase 4
SponsorInstitutul Clinic Fundeni
Started2022-03-02
Est. completion2028-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05207358
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
Age: 18 Years – 80 YearsHealthy volunteers accepted
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
Conditions2
LupusLupus Nephritis
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Actively Recruiting
PhasePhase 4
SponsorInstitutul Clinic Fundeni
Started2022-03-02
Est. completion2028-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05207358