Actively Recruiting
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Led by Institutul Clinic Fundeni · Updated on 2022-03-03
30
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed with systemic lupus erythematosus according to ACR 1997 or SLICC-2012 criteria
- Confirmed proliferative lupus nephritis class III, IV +/- V by kidney biopsy
- Estimated glomerular filtration rate (eGFR) by CKD-EPI greater than 30 ml/min/1.73 sqm
- Or eGFR between 15 and 30 ml/min/1.73 sqm with chronicity index less than 6
- No contraindications to Methylprednisolone, Mycophenolate mofetil, oral corticosteroids, or Rituximab
- Able to provide informed consent
You will not qualify if you...
- Age under 18 years
- Life-threatening complications such as cerebritis
- eGFR below 30 ml/min/1.73 sqm
- eGFR between 15 and 30 ml/min/1.73 sqm with chronicity index greater than 6
- Pregnancy or breastfeeding
- Received more than 2 g of intravenous Methylprednisolone in the last 4 weeks
- Use of biological therapy in the last 3 months
- Use of intravenous immunoglobulins or plasmapheresis in the last 6 months
- Active infection
- History of cancer
- Comorbidities requiring systemic corticosteroids
- Non-adherence to treatment or study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
Research Team
B
Bogdan Obrisca, MD, PhD
CONTACT
A
Alexandra Vornicu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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