Status:
RECRUITING
Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Université Catholique de Louvain
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus (SLE). Among people living with SLE, 35-60% will develop LN during the course of the disease. This complica...
Detailed Description
Study rationale Lupus nephritis (LN) affects 35-60% of patients with systemic lupus erythematosus (SLE), and constitutes one of the most severe disease manifestations. Several factors contribute to r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04449991
Start Date
January 5 2022
End Date
December 1 2028
Last Update
September 2 2025
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Sweden, 17676