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

RecruitingNAAges 18 Years - anyAllKarolinska Institutet
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In plain words

What the trial is, and whether it could suit you

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 complication is one of the factors that contribute to deterioration of the renal function. Some centres perform kidney biopsies after completion of treatment for an episode of LN as a part of the treatment evaluation. The term "repeat biopsy" is often used to describe these biopsies. Several studies have reported that repeat kidney biopsies show activity at the level of tissue, even in patients with normal routine blood and urine markers. The investigators strongly believe that this information is important, and should be taken into consideration during decision of treatment. To provide evidence for this, the investigators have designed a collaborative project within the frame of the Lupus Nephriti

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 1 g/g), i.e. 2003 ISN/RPS class III (A or A/C) ยฑ V, class IV (A or A/C) ยฑ 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/ฮผL, 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.
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What it tests

  • Repeat kidney biopsy
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Where

1 site
Karolinska University Hospital
Stockholm, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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