Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT05207358

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fundeni Clinical Institute

Bucharest, Romania, 022328

Actively Recruiting

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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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