NCT05207358 Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
| NCT ID | NCT05207358 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institutul Clinic Fundeni |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2022-03-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 remission induction by evaluating the histological and clinical remission.
Eligibility Criteria
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
Contact & Investigator
Gener Ismail, MD, PhD
PRINCIPAL INVESTIGATOR
Institutul Clinic Fundeni
Frequently Asked Questions
Who can join the NCT05207358 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05207358 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05207358 currently recruiting?
Yes, NCT05207358 is actively recruiting participants. Contact the research team at obriscabogdan@yahoo.com for enrollment information.
Where is the NCT05207358 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT05207358 clinical trial?
NCT05207358 is sponsored by Institutul Clinic Fundeni. The principal investigator is Gener Ismail, MD, PhD at Institutul Clinic Fundeni. The trial plans to enroll 30 participants.
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