NCT05207358RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Dec 2021
- Start date
- 2 Mar 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Institutul Clinic Fundeni
- Diseases
- Lupus (SLE)
- NCT number
- NCT05207358
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 2 Mar 2022 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Comorbidities requiring systemic corticosteroid therapy
Other illness
- The presence of an active infection
- History of neoplasia
Age
- The patient's age under 18 years
Other
- 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
- Use of intravenous immunoglobulins / plasmapheresis in the last 6 months
- Non-adhesion
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.