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Daratumumab in Treatment of PGNMID and C3 GN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03095118
Recruitment Status : Completed
First Posted : March 29, 2017
Results First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Membranoproliferative Glomerulonephritis Drug: Daratumumab Phase 2

Detailed Description:
This study is an open-label phase 2 trial of the safety and efficacy of daratumumab, in the treatment of PGNMID and C3GN associated with monoclonal gammopathy. Subjects will be screened at outpatient Nephrology Clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and follow-up for the next 12 months. Daratumumab will be administered once weekly for 8 weeks and then once every 2 weeks for 8 additional doses. Patients will be followed for a total of 12 months (6 months after the last infusion). A final visit for evaluation and collection of lab samples will be conducted at the end of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-center Phase 2 Open-label Trial Evaluating Efficacy and Safety of Daratumumab in Treatment of Patients With Proliferative Glomerulonephritis With Monoclonal Immune Deposits and C3 Glomerulopathy Associated With Monoclonal Gammopathy
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : October 14, 2019
Actual Study Completion Date : May 12, 2020


Arm Intervention/treatment
Experimental: Daratumumab
Subjects will receive daratumumab intravenously at a dose of 16 mg/kg once weekly for 8 weeks followed by once every 2 weeks for 8 additional doses
Drug: Daratumumab
Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
Other Name: Darzalex




Primary Outcome Measures :
  1. Number of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    Number of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.


Secondary Outcome Measures :
  1. Remission Status at 6 Months [ Time Frame: 6 months ]
    The number of subjects to reach either complete remission or partial remission at 6 months after infusion.

  2. Remission Status at 12 Months [ Time Frame: 12 months ]
    The number of subjects to reach either complete remission or partial remission at 12 months after infusion.

  3. Proteinuria at Baseline [ Time Frame: Baseline ]
    Measured using 24 hour urine collection reported in mg/24h

  4. Proteinuria at 6 Months [ Time Frame: 6 months ]
    Measured using 24 hour urine collection reported in mg/24 h

  5. Proteinuria at 12 Months [ Time Frame: 12 months ]
    Measured using 24 hour urine collection reported in mg/24h

  6. Serum Creatinine at Baseline [ Time Frame: Baseline ]
    Blood serum collected and reported in mg/dL

  7. Serum Creatinine at 6 Months [ Time Frame: 6 months ]
    Blood serum collected and reported in mg/dL

  8. Serum Creatinine at 12 Months [ Time Frame: 12 months ]
    Blood serum collected and reported in mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095118


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Fernando Fervenza
Investigators
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Principal Investigator: Fernando C Fervenza, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Fernando Fervenza, Mayo Clinic:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Fervenza, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03095118    
Other Study ID Numbers: 16-004805
First Posted: March 29, 2017    Key Record Dates
Results First Posted: July 16, 2021
Last Update Posted: July 16, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glomerulonephritis
Glomerulonephritis, Membranoproliferative
Nephritis
Kidney Diseases
Urologic Diseases
Immune System Diseases
Daratumumab
Antineoplastic Agents