Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

Completed · Phase 2

Conditions studied: Fibrillary Glomerulonephritis

In brief

This pilot study is being done to see if the study medication, Rituximab, preserves kidney function after 12 months of taking the drug.

Key facts

Study ID

NCT02197767

Run by

Mayo Clinic

People needed

11

Starts

2014-11-01

Expected to finish

2017-04-01

Last updated by the study team

2019-02-06

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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