Phase 2 Lupus Trial, Recruiting NCT05508009 Sponsor: Alice Bertaina Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT05508009
Recruiting Phase 2

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 expected to need a kidney transplant because of a genetic or immune system disease (such as SIOD, FSGS, Cystinosis, Lupus/SLE, certain types of kidney inflammation, or other genetic conditions causing kidney disease), OR because your body previously rejected a kidney transplant.
  • You have been diagnosed with chronic kidney disease at stage 3 or higher.
  • You are taking steroids at a low dose (less than 0.5 mg per kilogram of body weight per day).
  • Your donor's and your own tissue types (called HLA markers) must closely match at specific points checked by detailed testing.
  • You are well enough to perform daily activities, as measured by a standard health scoring tool (a score above 50 on either the Karnofsky or Lansky scale, depending on your age).
  • You are able to give your own consent to join the study, or someone legally allowed to consent on your behalf is available.
  • If you are able to have children (male or female), you must agree to use effective birth control during the transplant process, while on anti-rejection medicines, and if certain transplant-related complications occur.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have had a serious transplant-related immune reaction (called GvHD) from a previous transplant that is severe or not well controlled.
  • You have significant liver problems, as shown by certain blood test results being much higher than normal.
  • You have serious heart problems that have not improved with nutritional support or dialysis, including poor heart pumping function or severe heart stiffness.
  • You currently have an active, uncontrolled infection (note: people with HIV, Hepatitis B, or Hepatitis C may still be eligible if their virus is undetectable and well managed — confirm with trial site).
  • You have another serious uncontrolled medical condition, apart from the kidney disease that is the reason for joining the trial.
  • You or your parent/guardian are unable or unwilling to give informed consent.
  • You have any other serious illness that, in the opinion of the study doctor, would put you at increased risk by taking part.

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 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Alice Bertaina
Registry
ClinicalTrials.gov
Start date
10 January 2023
Est. completion
1 October 2032

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of patients who are able to discontinue immunosuppression post-KT

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