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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Mayo Clinic
Study ID
NCT01573533
Phase
PHASE2
Status
Completed

Conditions

  • Primary Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
Jan 2020
Primary completion
Nov 15, 2018
Completion
Nov 15, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Changes in Proteinuria (With Stable Renal Function) [ Time Frame: Baseline, 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
Mayo Clinic College of MedicineRochesterMinnesota55905-

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILMayo Clinic College of Medicine· Rochester, MN

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