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Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

Primary Purpose

Fibrillary Glomerulonephritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrillary Glomerulonephritis focused on measuring fibrillary glomerulonephritis, rituximab, Rituxan, MabThera, Zytux™

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in 24 Hour Creatinine Clearance
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
Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.

Full Information

First Posted
July 21, 2014
Last Updated
January 16, 2019
Sponsor
Mayo Clinic
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02197767
Brief Title
Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis
Official Title
A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrillary Glomerulonephritis
Keywords
fibrillary glomerulonephritis, rituximab, Rituxan, MabThera, Zytux™

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
1000 mg infusion
Primary Outcome Measure Information:
Title
Change in 24 Hour Creatinine Clearance
Description
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).
Time Frame
Day 0, Day 365
Secondary Outcome Measure Information:
Title
Change in Proteinuria
Description
Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.
Time Frame
Day 0, Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B. Erickson, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32617582
Citation
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.
Results Reference
derived

Learn more about this trial

Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

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