- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095118
Daratumumab in Treatment of PGNMID and C3 GN
August 26, 2022 updated by: Fernando Fervenza
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
12 months
|
Proteinuria at Baseline
Time Frame: Baseline
|
Measured using 24 hour urine collection reported in mg/24h
|
Baseline
|
Proteinuria at 6 Months
Time Frame: 6 months
|
Measured using 24 hour urine collection reported in mg/24 h
|
6 months
|
Proteinuria at 12 Months
Time Frame: 12 months
|
Measured using 24 hour urine collection reported in mg/24h
|
12 months
|
Serum Creatinine at Baseline
Time Frame: Baseline
|
Blood serum collected and reported in mg/dL
|
Baseline
|
Serum Creatinine at 6 Months
Time Frame: 6 months
|
Blood serum collected and reported in mg/dL
|
6 months
|
Serum Creatinine at 12 Months
Time Frame: 12 months
|
Blood serum collected and reported in mg/dL
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fernando C Fervenza, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2017
Primary Completion (Actual)
October 14, 2019
Study Completion (Actual)
May 12, 2020
Study Registration Dates
First Submitted
March 20, 2017
First Submitted That Met QC Criteria
March 23, 2017
First Posted (Actual)
March 29, 2017
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-004805
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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