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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
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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

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 :
  1. 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
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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