Overview

This trial is active, not recruiting.

Condition fibrillary glomerulonephritis
Treatment rituximab
Phase phase 2
Target CD20
Sponsor Mayo Clinic
Collaborator Genentech, Inc.
Start date November 2014
End date April 2017
Trial size 11 participants
Trial identifier NCT02197767, 13-006694

Summary

Will use of Rituximab reduce proteinuria over a 12 month period and will there be preservation of kidney function with the use of this study drug?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
rituximab Rituxan
After successful enrollment, patients will be treated with an infusion dose of rituximab at Day 1 and at Day 15. CD 20+ cell count will be drawn pre and post infusion at Day 1, Day 28, Day 181, and Day 365. Patients will be retreated with a second dose of rituximab at 6 months independently of CD 20+ cell count.

Primary Outcomes

Measure
Preservation of kidney function
time frame: 12 months

Secondary Outcomes

Measure
Reduction in proteinuria
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Single Center Pilot Trial of Rituximab in the Treatment of Fibrillary Glomerulonephritis
      Principal investigator Stephen B. Erickson, M.D.
      Description This is a Phase II, open-label 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. Aim 1) Preservation of kidney function at 12 months as defined by stable or improved 24 hour creatinine clearance. Aim 2) Reduction in proteinuria at 12 months & improved quality of life at 12 months validated by questionnaire.
      Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
      Information provided to ClinicalTrials.gov by Mayo Clinic.