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A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS

NCT01573533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-02-10

Study results available
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Summary

The purpose of this study is to determine whether Rituximab therapy is safe and effective in treating patients with the kidney condition, focal segmental glomerulosclerosis (FSGS), that is no longer responsive to traditional therapies.

Conditions

  • Primary Focal Segmental Glomerulosclerosis

Interventions

BIOLOGICAL

Rituximab

Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.

Sponsors & Collaborators

  • University Health Network, Toronto

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Rush University Medical Center

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michelle Hladunewich, MD, MSc, BSc · University Health Network, Sunnybrook Health Sciences Centre

  • Fernando C Fervenza, MD, PhD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-11-15
Completion
2018-11-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573533 on ClinicalTrials.gov