Open-label Trial of Daratumumab in Treatment of PGNIMD and C3 GN

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Closed for enrollment

Contact information:

Julie Ray CCRP

(507) 266-5363

Ray.Julie@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Contact us for the latest status

Contact information:

Jasmine Evans

(904)953-8551

Kennedy-Evans.Jasmine@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312641

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