Cancer drug shows promise for lupus kidney disease
NCT ID NCT04868838
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
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Apr 2021
- Expected to finish
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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