Can a cancer drug rescue kidneys harmed by rogue antibodies?
NCT ID NCT06889948
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether the drug daratumumab can treat kidney diseases caused by monoclonal gammopathy of renal significance (MGRS), a group of conditions where abnormal antibody proteins damage the kidneys. The trial enrolls 30 adults with biopsy-confirmed MGRS. Participants receive daratumumab alone or with a stem cell transplant, and researchers measure changes in kidney function, protein in urine, and blood markers of the abnormal antibodies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- daratumumab, a drug that targets antibody-producing cells
- What this could lead to
- If daratumumab helps, it could offer a targeted treatment for kidney diseases caused by abnormal antibody proteins, potentially preserving kidney function and reducing the need for dialysis.
- What could go wrong
- This is a small Phase 2 trial with 30 participants, so results may not apply to everyone. Daratumumab can cause infusion reactions and may not improve kidney function in all types of MGRS.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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: 1. Males or females ≥ 18 years of age 2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. 3. Renal biopsy confirmed MGRS-disease * Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted. * Renal transplant patients are allowed 4. Amount of proteinuria ≥ 500 mg/24 h OR eGFR ≥ 20 ml/min prior to the study 5. Previous anticlonal treatment is allowed if deemed ineffective Exclusion Criteria: 1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included) 2. Cancer that requires treatment, 3. MGRS related to B-cell malignant disorders, 4. Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study), 5. Pregnancy or breastfeeding, 6. Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment; * prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed. * mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation. 7. In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required. 8. Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and/or hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Helsinki University Hospital
RECRUITINGHelsinki, Finland
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Other studies related to the condition(s) this trial covers.
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- Aging kidneys under the microscope: could a simple test predict failure?