Phase 4 Lupus Trial, Recruiting NCT05207358 Sponsor: Institutul Clinic Fundeni Condition: Lupus
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Phase 4 Lupus Trial, Recruiting

NCT05207358
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 80 years old
  • You have been diagnosed with systemic lupus erythematosus (lupus/SLE) based on recognised medical guidelines
  • You have been diagnosed with a specific type of kidney inflammation caused by lupus (called proliferative lupus nephritis, class III, IV, or V), confirmed by a kidney biopsy
  • Your kidneys are working at a reasonable level, as measured by a specific kidney function test (confirm with trial site for exact values)
  • You are able to take certain medications used in this trial, including Methylprednisolone, Mycophenolate mofetil, steroids, or Rituximab, without medical contraindications
  • You are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

  • You are under 18 years old
  • You have life-threatening complications from your lupus, such as brain inflammation
  • Your kidney function is too low, as measured by a specific kidney function test (confirm with trial site for exact values)
  • You are currently pregnant or breastfeeding
  • You have received high doses of a steroid called Methylprednisolone by drip (IV) in the last 4 weeks
  • You have used a type of medication called biological therapy in the last 3 months
  • You have received intravenous immunoglobulins or a blood-filtering treatment called plasmapheresis in the last 6 months
  • You currently have an active infection
  • You have a history of cancer
  • You have another medical condition that already requires you to take steroid medication regularly
  • You are unlikely to follow the trial's treatment plan or attend appointments (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Gener Ismail, MD, PhD, Institutul Clinic Fundeni

Phone: 0040721256797

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Institutul Clinic Fundeni
Registry
ClinicalTrials.gov
Start date
2 March 2022
Est. completion
31 December 2028

Where this trial is recruiting

🇷🇴 Romania

Primary endpoints

Percentage of participants with a histological remission

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov