Tests repeat kidney biopsies in people with a first flare of lupus nephritis
Compares a repeat kidney biopsy after treatment with no repeat biopsy in lupus nephritis.
Key facts
- Who runs it
- Karolinska Institutet
- Where
- Stockholm, SwedenSee the site
- Trial code
- Registry title
- Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
- Status
- Recruiting
- People taking part
- 206 people, planned
- Started
- 5 Jan 2022
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Repeat kidney biopsy
- Record updated
- 2 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE) who have a first episode of lupus nephritis (kidney inflammation from lupus) proven by kidney biopsy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- A first episode of biopsy-proven proliferative or membranous lupus nephritis (ISN/RPS class III, IV, V or III/IV plus V), with urine protein-to-creatinine ratio (UPCR) of 1 g/g or more.
- Earlier treatment
- People start standard treatment: IV methylprednisolone pulses, oral prednisone, hydroxychloroquine (unless not allowed), an ACE inhibitor or ARB, and either mycophenolate mofetil or IV cyclophosphamide.
- Biomarker or test result
- Meets the EULAR/ACR classification criteria for SLE. UPCR of 1 g/g or more.
Main reasons for not taking part
- Antiphospholipid syndrome nephropathy
- Pregnant at the start of the trial
- A medical reason that rules out a kidney biopsy (for example, low platelets below 50,000/μL, uncontrolled high blood pressure or end-stage kidney disease)
- Expected not to follow the treatment
- Cannot read or sign the consent form
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Anticipated non-adherence to therapy
- Antiphospholipid syndrome nephropathy (APSN)
- Medical contraindications to kidney biopsy, e.g. thrombocytopenia < 50,000/μL, uncontrolled hypertension or end-stage kidney disease (ESKD)
- Medical conditions interfering with outcome evaluations
- Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion)
- Inability to read and/or sign the informed consent form
Where in Sweden
- Karolinska University HospitalStockholm, SwedenContact: Ioannis Parodis, MD PhD | Associate ProfessorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 Nephritis Trials Network. With this research project, the investigators want to contribute to an increased proportion of patients with LN who achieve remission (inactivity) of LN, and a reduced proportion of patients who worsen in renal function in the long term.
Patients with SLE who develop a first episode of LN will be asked to participate in this project, and will receive treatment according to current guidelines. Half of the patients will undergo a repeat biopsy 12 months later, and half of the patients will not. The selection of patients who will undergo or not undergo repeat biopsy will be random. Patients with high disease activity at the level of kidney tissue will receive more intense immunosuppressive treatment. Patients who have not undergone repeat biopsy will continue to be treated according to standard routine.
The investigators will compare the results of treatment between the group of patients who underwent and the group of patients who did not undergo repeat biopsy, with regard to (i) complete disease inactivity at month 24 and (ii) renal function at month 60 from treatment initiation.
The investigators expect that significantly greater proportions of patients in the repeat biopsy group will have inactive disease at month 24 and adequate levels of renal function at month 60. This will provide support for performing repeat biopsies as a part of the treatment evaluation, in order to optimise the therapeutic management and improve the long-term prognosis of patients with LN.
The 2 groups in the trial
- Intervention arm: Repeat kidney biopsy at M12Treatment being tested
Patients will undergo repeat kidney biopsy at month 12 from baseline.
Treatment: Repeat kidney biopsy
- Control arm: No repeat kidney biopsyNo study treatment, for comparison
Patients will not undergo repeat kidney biopsy at month 12 from baseline.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis
- Plain-language title
- Tests repeat kidney biopsies in people with a first flare of lupus nephritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 September 2025