Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT03095118
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03095118
Study Brief:
Protocol Section:
NCT03095118