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

Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

Stephen B. Erickson, M.D., Mayo Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Fibrillary Glomerulonephritis	Drug: rituximab	Phase 2

Detailed Description:

This is a Phase II, open-label pilot 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. Each patient will be treated with 2 intravenous infusions of rituximab 1000 mg, two weeks apart for a total of 2 doses. Each patient will be retreated with identical 2 intravenous infusions of rituximab, two weeks apart at 6 months after the first infusion, irrespective of cluster of differentiation (CD) 20+ cell counts. Thus, each participant will receive 4 infusions of rituximab.

Study Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Genetic and Rare Diseases Information Center resources: Glomerulonephritis Fibrillary Glomerulonephritis

U.S. FDA Resources

Arms and Interventions

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.	Drug: rituximab 1000 mg infusion Other Name: Rituxan

Outcome Measures

Primary Outcome Measures :

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).

Secondary Outcome Measures :

Change in Proteinuria [ Time Frame: Day 0, Day 365 ]
Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Genentech, Inc.

Investigators

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Principal Investigator:	Stephen B. Erickson, M.D.	Mayo Clinic

Study Documents (Full-Text)

Documents provided by Stephen B. Erickson, M.D., Mayo Clinic:

Study Protocol and Statistical Analysis Plan [PDF] March 7, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Erickson SB, Zand L, Nasr SH, Alexander MP, Leung N, Drosou ME, Fervenza FC. Treatment of fibrillary glomerulonephritis with rituximab: a 12-month pilot study. Nephrol Dial Transplant. 2021 Jan 1;36(1):104-110. doi: 10.1093/ndt/gfaa065.

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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

Keywords provided by Stephen B. Erickson, M.D., Mayo Clinic:


fibrillary glomerulonephritis rituximab Rituxan MabThera Zytux™

Additional relevant MeSH terms:

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Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases Rituximab	Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

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