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

Primary Focal Segmental Glomerulosclerosis Clinical Trial

Official title: A Pilot Study to Assess the Efficacy of Rituximab Therapy in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS): Integrating an Assessment of the Relevance of suPAR and Activation of Podocyte β3 Integrin

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a pilot trial to assess the safety, feasibility and efficacy of Rituximab therapy in 20 adult and pediatric patients with either steroid and/or calcineurin inhibitor resistant FSGS or with a significant intolerance or contraindication to the use of these agents. In addition to clinical criteria, elevated levels of suPAR will define inclusion. Changes in the baseline levels of the potential biomarkers (suPAR, as well as activation of beta-3 integrin) in response to treatment will be compared to clinical measures of efficacy.

Participants will have a screening/baseline visit to confirm eligibility within 6 weeks prior to the first of two Rituximab infusions (at Day 1 and Day 15). Participants will then attend follow up visits at 1, 3, 6 and 12 months after Rituximab treatment to assess adverse events and collect safety blood and urine samples. ;

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal Segmental
• Primary Focal Segmental Glomerulosclerosis

• NCT number: NCT01573533
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Completion date: November 15, 2018