Cancer drug shows promise for lupus kidney disease

NCT ID NCT04868838

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This phase 2 trial tests whether daratumumab, a drug used for multiple myeloma, can help people with active lupus nephritis—a serious kidney complication of lupus. The study enrolls adults with confirmed lupus and active kidney inflammation. Participants receive daratumumab injections, and researchers monitor for kidney function improvement and side effects.

What this could mean

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

Active substance
daratumumab
What this could lead to
If successful, daratumumab could offer a new treatment option for lupus nephritis, potentially reducing kidney damage and the need for long-term immunosuppression.
What could go wrong
This is a small, early-phase trial with only 12 participants, so results may not apply broadly. Daratumumab can cause infections and other side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

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

Started

Apr 2021

Expected to finish

Sep 2026

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: * Age ≥ 18 years of age. * Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria. * Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12 months of enrollment. * Proteinuria ≥ 500 mg over 24 hours. * eGFR ≥ 30 ml/min/SA. * Subjects should be able to give informed consent. Exclusion Criteria: * Pregnancy. * Hepatitis B or C, HIV * Anemia with Hgb \< 8.0 g/dL. * Thrombocytopenia with platelet count \< 100'000. * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication. * Unable to provide consent. * Patients receiving \> 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for \> 2 weeks (patients would be allowed to be on \> 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks). * Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months. * Patients who have received cyclophosphamide in the last 6 months. * Patients who received rituximab previously with CD20 count of zero at the time of enrollment. * Patient are allowed to be on MMF at time of enrollment but no higher than total of 1500mg/day. * For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug. * For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period. * Patients with diagnosis of glaucoma.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

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