CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Rituximabbiological
Likely dose
Rituximab 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01573533
NCT01573533Phase 2Completed
CompareCT.gov

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

Mayo Clinic·interventional·Posted Apr 9, 2012·Updated Feb 10, 2020

In Brief

A Phase 2 clinical trial evaluating Rituximab for Primary Focal Segmental Glomerulosclerosis. Completed, enrolled 9 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Focal Segmental Glomerulosclerosis
CountriesCanada, United States
CollaboratorsUniversity Health Network, Toronto, National Institutes of Health (NIH), Genentech, Inc., Rush University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2012
Enrollment StartOct 1, 2013
Primary CompletionNov 15, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 14.2 years ago

Interventions

Rituximabbiological

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.