Phase 2
Completed N=12
Daratumumab in Treatment of PGNMID and C3 GN
Membranoproliferative Glomerulonephritis
Source: ClinicalTrials.gov NCT03095118 ↗
Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Treatment-Emergent Adverse Events — 5 Serious Adverse Events
Summary
This study is being done to see if daratumumab is safe and effective in the treatment of proliferative glomerulonephritis with monoclonal immune deposits (PGNMID) and C3 glomerulopathy associated with monoclonal gammopathy (C3GN). This is an inflammatory disease in the kidney due to the production of abnormal proteins. There are no known standard effective treatments for patients with PGNMID and C3GN secondary to monoclonal gammopathy. These diseases are caused by abnormal production of proteins (monoclonals) by abnormal clones. Daratumamb has been shown to be effective in treating patients with multiple myeloma a disease which also caused by over production of monoclonal proteins from abnormal clones. Everyone in this study will receive daratumumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Emergent Adverse Events |
5 | — |
| SECONDARY Remission Status at 6 Months |
8 | — |
| SECONDARY Remission Status at 12 Months |
9 | — |
| SECONDARY Proteinuria at Baseline |
4346 | — |
| SECONDARY Proteinuria at 6 Months |
702 | 0.001 sig |
| SECONDARY Proteinuria at 12 Months |
1264 | 0.004 sig |
| SECONDARY Serum Creatinine at Baseline |
1.36 | — |
| SECONDARY Serum Creatinine at 6 Months |
1.25 | 0.15 |
| SECONDARY Serum Creatinine at 12 Months |
1.25 | 0.16 |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years of age
- Renal biopsy read at Mayo Clinic confirming the diagnosis of PGNMID or C3 GN
- In cases of C3GN serum electrophoresis with immunofixation should confirm presence of monoclonal gammopathy
- Proteinuria ≥ 1000 mg over 24 hours
- eGFR ≥ 20 mL/min/SA
- Subjects able and willing to give informed consent
Exclusion Criteria
- Pregnancy
- Hepatitis B or C, HIV
- Multiple myeloma
- Anemia with Hgb < 8.5 g/dL
- Thrombocytopenia with platelet count < 100,000
- Leukopenia with WBC < 3.5
- 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 therapy with oral prednisone or glucocorticoid equivalent in the last 6 weeks
- Patients who had received immunosuppressive therapy including cyclophosphamide, MMF, cyclosporine, tacrolimus or azathioprine in the last 3 months
- Patients who received rituximab previously with CD20 count of zero at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT03095118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.