Lupus Trial, Recruiting NCT04449991 Sponsor: Karolinska Institutet Condition: Lupus
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Lupus Trial, Recruiting

NCT04449991
Recruiting Not Applicable

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:

  • People who have been formally diagnosed with Systemic Lupus Erythematosus (SLE) according to recognised international classification standards
  • People who are 18 years of age or older
  • People who have a newly diagnosed form of lupus kidney disease (lupus nephritis), confirmed by a kidney biopsy, showing specific types of kidney involvement (classified as certain grades of kidney damage, with a protein-to-creatinine ratio of at least 1 g/g — confirm with trial site for full details)
  • People who agree to the possibility of having a second kidney biopsy at 12 months after joining the trial
  • People who are starting a specific treatment plan that includes steroid infusions, daily oral steroids with a tapering schedule, hydroxychloroquine (unless medically unsuitable), blood pressure-protective medications (ACE inhibitors or ARBs), and either mycophenolate mofetil or intravenous cyclophosphamide — with optional add-on treatments in some cases

Who may not be able to join:

  • People who have a related kidney condition caused by antiphospholipid syndrome (a separate blood clotting disorder affecting the kidneys)
  • People who are pregnant at the time of joining the trial (becoming pregnant during the trial does not automatically lead to removal from the study)
  • People for whom a kidney biopsy would be medically unsafe — for example, those with a very low platelet count, uncontrolled high blood pressure, or severe kidney failure
  • People who are considered unlikely to follow the required treatment plan consistently
  • People who have other medical conditions that could interfere with measuring the trial's results
  • People who are unable to read and/or sign the consent form

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ioannis Parodis, MD PhD, Karolinska Institutet

Phone: +46722321322

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
5 January 2022
Est. completion
1 December 2028

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Complete Renal Response (CRR) at month 24 from baseline

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