Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
This trial is active, not recruiting.
|Start date||November 2014|
|End date||April 2017|
|Trial size||11 participants|
|Trial identifier||NCT02197767, 13-006694|
Will use of Rituximab reduce proteinuria over a 12 month period and will there be preservation of kidney function with the use of this study drug?
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Preservation of kidney function
time frame: 12 months
Reduction in proteinuria
time frame: 12 months
Male or female participants from 18 years up to 79 years old.
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 ACEi and/or 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 GFR > 25 mL/min using 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 ANC: > 1000/ mm3 (Absolute Neutrophil Count) Adequate liver function, as indicated by AST, ALT, alkaline phosphatase and total bilirubin < 2x upper limit or normal unless related to primary disease Negative HBsAg and anti-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
|Official title||A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis|
|Principal investigator||Stephen B. Erickson, M.D.|
|Description||This is a Phase II, open-label study to determine if the use of Rituximab reduces proteinuria over a 12 month period and is there preservation of kidney function with the use of this study drug. Aim 1) Preservation of kidney function at 12 months as defined by stable or improved 24 hour creatinine clearance. Aim 2) Reduction in proteinuria at 12 months & improved quality of life at 12 months validated by questionnaire.|
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