Phase 4 Lupus Trial, Recruiting NCT05916781 Sponsor: Chinese SLE Treatment And Research Group Condition: Lupus
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Phase 4 Lupus Trial, Recruiting

NCT05916781
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 have been diagnosed with lupus (systemic lupus erythematosus) and your lupus has affected your kidneys (lupus nephritis), based on specific medical classification guidelines.
  • Your lupus has been well-controlled and stable for at least 6 months, meaning your urine protein levels are low, your kidney function is stable, your lupus activity score is at zero (or near zero), and your doctor has rated your overall disease activity as very low.
  • You are taking a low dose of steroids (prednisone or equivalent, 5mg per day or less), using a stable dose of immune-suppressing or antimalarial medications, and are not currently using any biological therapy drugs.
  • Your doctor believes this treatment is appropriate for you.
  • You are willing to take part, are able to follow the study requirements, and can understand and sign a consent form before the study begins.

Who may not be able to join:

  • You have serious problems with a major organ, such as confusion or memory issues, poor kidney function, significant heart failure, high blood pressure in the lungs, or scarring lung disease.
  • Your lupus is currently active in a major organ, such as the kidneys, brain, blood (very low platelets or red blood cell destruction), heart, or digestive system.
  • You are allergic to or cannot tolerate the medications mycophenolate mofetil or tacrolimus.
  • You currently have an active infection or a long-term infection that needs treatment, including tuberculosis, Hepatitis B, Hepatitis C, HIV, or CMV.
  • You are pregnant or planning to become pregnant.
  • You have used biological therapy drugs within the last 6 months before joining the trial.
  • The trial doctor has identified any other condition that could put you at risk or prevent you from completing the study (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 26 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: Mengtao Li, MD, Peking Union Medical College Hospital

Phone: 86-13426191948

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
Chinese SLE Treatment And Research Group
Registry
ClinicalTrials.gov
Start date
1 July 2023
Est. completion
31 July 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period.

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: 26 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