Repeat kidney biopsy for lupus nephritis patients

Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis

This study tests whether doing repeat kidney biopsies can help doctors make better treatment decisions for patients with lupus nephritis by looking at tissue changes even when symptoms seem normal.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Karolinska Institutet (other)
• Drugs / interventions: cyclophosphamide, prednisone
• Locations: 1 site (Stockholm)
• Trial ID: NCT04449991 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven proliferative or membranous lupus nephritis.

Not a fit: Patients with non-proliferative lupus nephritis or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and better long-term kidney health for patients with lupus nephritis.

How similar studies have performed: Previous studies have shown promising results regarding the importance of repeat kidney biopsies in treatment evaluation, suggesting this approach may be beneficial.

Eligibility criteria

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 this trial is running

Stockholm

• Karolinska University Hospital — Stockholm, Sweden (RECRUITING)

Study contacts

• Study coordinator: Ioannis Parodis, MD PhD | Associate Professor

Conditions: Lupus Nephritis, systemic lupus erythematosus, lupus nephritis, kidney biopsy, renal function impairment, long-term prognosis, electron microscopy