Repeat kidney biopsy for lupus nephritis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the role of repeat kidney biopsies in patients with lupus nephritis, a severe complication of systemic lupus erythematosus. It aims to evaluate the histopathological findings post-treatment to better inform treatment decisions. By analyzing tissue activity even when clinical markers appear normal, the study seeks to improve long-term renal outcomes for affected patients. The research is conducted within the Lupus Nephritis Trials Network, emphasizing the importance of tissue evaluation in treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident biopsy-proven proliferative or membranous LN, or combinations thereof (with UPCR ≥ 1 g/g), i.e. 2003 ISN/RPS class III (A or A/C) ± V, class IV (A or A/C) ± V, or class V.
* Consent to the possibility of a repeat kidney biopsy at month 12 from baseline.
* Initiation of the following treatment regimens:

  * intravenous pulses of methylprednisolone (total dose of 500-3000 mg);
  * oral prednisone or equivalent 0.3-0.5 mg/kg/day with tapering;
  * hydroxychloroquine unless contraindicated;
  * angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs);
  * either one of mycophenolate mofetil (MMF) equivalent dose 2-3 g/day, or IV cyclophosphamide (CYC) according to the Euro-Lupus regimen;
  * the NIH protocol for IV CYC (0.5-0.75 g/m2 monthly for six months) could be considered in severe cases;
  * add-on therapies (e.g. calcineurin inhibitors, biologics) to the above two regimens are optional.

Exclusion Criteria:

* Antiphospholipid syndrome nephropathy (APSN).
* Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
* Medical contraindications to kidney biopsy, e.g. thrombocytopenia \< 50,000/μL, uncontrolled hypertension or end-stage kidney disease (ESKD).
* Anticipated non-adherence to therapy.
* Medical conditions interfering with outcome evaluations.
* Inability to read and/or sign the informed consent form.

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Ioannis Parodis, MD PhD | Associate Professor
• Email: ioannis.parodis@ki.se
• Phone: +46722321322

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.