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Second look inside the kidney: could repeat biopsies save lupus Patients' kidneys?

NCT ID NCT04449991

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether doing a repeat kidney biopsy one year after starting treatment for lupus nephritis can help doctors decide if more treatment is needed. Half of the 206 participants will get the repeat biopsy, and the other half will follow standard care. The goal is to see if the biopsy group has better kidney function and fewer relapses over two to five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that repeat biopsies help doctors tailor treatment to reduce kidney damage in lupus nephritis patients.
What could go wrong
This is an observational/procedural study, not testing a new drug. The benefit of repeat biopsy is uncertain, and biopsies carry small risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17676, Sweden

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