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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02197767
Eligibility Criteria:
Inclusion Criteria:
* Fibrillary Glomerulonephritis with diagnostic biopsy performed within the last 2 years
* Proteinuria \>1 gram
* Age \> 18 years but \< 80 years
* Adequately controlled blood pressure (BP\<140/90 mmHg in \>75% of the readings) for at least 3 months prior to enrollment with the use of (angiotensin converting enzyme inhibitors (ACEi) and/or angiotensin-receptor blockers (ARB), if tolerated.
* Women must be post- menopausal, surgically sterile or practicing a medically approved method of contraception
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Adequate renal function as indicated by estimated glomerular filtration rate (GFR) \> 25 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD/EPI) formula or a quantified creatinine clearance \>25 mL/min, and/or serum creatinine \<3.0 mg/dL in the presence of ACEi/ARB therapy
* Adequate bone marrow function, as indicated by hemoglobin \>7.0 gm/dL, white count \>3.0 x 10(9), platelet count \>100 x 10(9)
* Negative chest x-ray within one year
* Negative serum pregnancy test (for women of child bearing age)
* Normal organ function.
* Subject agrees to use an acceptable method of birth control during treatment and for twelve months after completion of treatment
* Subject has provided written informed consent
* Subject agrees to discontinue routine use of non-steroidal anti-inflammatory drugs
* Absolute Neutrophil Count (ANC): \> 1000/ mm3
* Adequate liver function, as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and total bilirubin \< 2x upper limit or normal unless related to primary disease
* Negative HBsAg and anti-hepatitis B (HBc) lab values within 1 year of signing consent
Exclusion Criteria:
* Pregnancy (determined by a serum pregnancy test for all women of childbearing potential within 7 days of treatment), or lactating.
* Inability to comply with study and/or follow-up procedures
* History of HIV (a documented positive lab value within one year of enrollment)
* Presence of active infection
* New York Heart Association Classification III or IV heart disease
* Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* History of psychiatric disorder
* At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to randomization
* At the Investigator's discretion, positive Hepatitis C serology
* Known history of diabetes mellitus or a Hemoglobin A1c result \> 6.0% within 90 days prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02197767
Study Brief:
Protocol Section:
NCT02197767