Pilot Study of Rituximab to Treat Fibrillary Glomerulonephritis

January 16, 2019 updated by: Stephen B. Erickson, M.D., Mayo Clinic

A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 0, Day 365

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Genentech, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-006694

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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