Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
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ClinicalTrials.gov Identifier: NCT02197767 |
Recruitment Status :
Completed
First Posted : July 23, 2014
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
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Condition or disease | Intervention/treatment | Phase |
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Fibrillary Glomerulonephritis | Drug: rituximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis |
Study Start Date : | November 2014 |
Actual Primary Completion Date : | April 2017 |
Actual Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: rituximab
rituximab 1000 mg infusion two weeks apart for a total of two infusions. Retreated with identical rituximab 1000 mg infusion two weeks apart at six months after the first infusion for a grand total of four infusions.
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Drug: rituximab
1000 mg infusion
Other Name: Rituxan |
- Change in 24 Hour Creatinine Clearance [ Time Frame: Day 0, Day 365 ]Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).
- Change in Proteinuria [ Time Frame: Day 0, Day 365 ]Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197767
United States, Minnesota | |
Mayo Clinic in Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Stephen B. Erickson, M.D. | Mayo Clinic |
Documents provided by Stephen B. Erickson, M.D., Mayo Clinic:
Responsible Party: | Stephen B. Erickson, M.D., PI, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT02197767 |
Other Study ID Numbers: |
13-006694 |
First Posted: | July 23, 2014 Key Record Dates |
Results First Posted: | February 6, 2019 |
Last Update Posted: | February 6, 2019 |
Last Verified: | January 2019 |
fibrillary glomerulonephritis rituximab Rituxan MabThera Zytux™ |
Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Rituximab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |