Actively Recruiting
Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits
Led by Mayo Clinic · Updated on 2025-09-16
40
Participants Needed
4
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in people with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID).
CONDITIONS
Official Title
Daratumumab for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PGNMID confirmed by renal biopsy at Mayo Clinic
- Proteinuria of 1000 mg or more over 24 hours
- Creatinine clearance of 20 mL/min/SA or higher
- Able and willing to provide informed consent
- Female participants of childbearing potential must commit to abstinence or use two reliable birth control methods during treatment and for 3 months after last dose
- Female participants must have two negative pregnancy tests before dosing
- Female participants must agree not to donate eggs during the study and for 3 months after last dose
- Male participants of reproductive potential who are sexually active with females must use condoms during the study and for 3 months after last dose
- Male participants must not donate sperm during the study and for 3 months after last dose
- Signed informed consent form or legally acceptable representative consent
You will not qualify if you...
- Pregnant or planning to become pregnant
- HIV positive
- Hepatitis C positive unless aviremic for at least 12 weeks after antiviral treatment
- Hepatitis B positive including resolved infection markers except vaccinated individuals without active infection
- Multiple myeloma with >10% plasma cells on bone marrow biopsy and M-spike >3 g/dL with myeloma defining events, or plasma cells >60%, or abnormal free light chain ratio
- Severe anemia (Hgb < 8.0 g/dL), thrombocytopenia (platelets < 75,000), leukopenia (WBC < 3.5), or neutropenia (ANC < 1000)
- Liver enzymes AST/ALT > 2.5 times upper limit of normal, bilirubin > 2 times upper limit
- COPD with FEV1 < 50% predicted
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma
- Significant cardiac disease including recent myocardial infarction, unstable angina, congestive heart failure NYHA III-IV, or uncontrolled arrhythmia
- Prior exposure to daratumumab or anti-CD-38 therapies (unless re-treatment study)
- Recent investigational drug or invasive device exposure within 4 weeks or 5 half-lives
- Recent focal radiation therapy within 14 days except palliative
- Other diseases or conditions that may interfere with treatment or study interpretation
- Unable to provide consent
- Recent use of oral prednisone or glucocorticoids in last 4 weeks unless low dose for unrelated conditions
- Recent use of certain immunosuppressive therapies in last 3 months unless discontinued for at least 7 days with no proteinuria improvement
- Prior cyclophosphamide or bortezomib only if no response
- Prior rituximab with low CD20 count at enrollment
- Live attenuated vaccine within 4 weeks before study drug
- History of malignancy except certain skin cancers or in situ lesions treated and disease-free for at least 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
University North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
Research Team
C
Corbyn Bendtsen
CONTACT
N
Nicholas Geroux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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