CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Intravenous Rituximab +2 moredrug
Likely dose
Not stated in 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/NCT00498368
NCT00498368Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Prospective, Open-Label Trial of Rituximab in the Treatment of Progressive IgA Nephropathy

Mayo Clinic·interventional·Posted Jul 10, 2007·Updated Feb 1, 2017

In Brief

A Phase 4 clinical trial evaluating Intravenous Rituximab, ACE/ARB, and 1 other intervention for IgA Nephropathy. Completed, enrolled 34 participants across 5 sites.

Detailed Summary

This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine. Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIgA Nephropathy
CountriesUnited States
CollaboratorsOhio State University, Stanford University, University of North Carolina, Chapel Hill, Columbia University, Genentech, Inc., Biogen

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2007
Enrollment StartFeb 1, 2009
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 19.0 years ago

Interventions

Intravenous Rituximabdrug

Rituximab Therapy \[27 Patients\] * Rituximab 1 gm IV on Treatment Day 1 * Rituximab 1 gm IV on Treatment Day 15 * Rituximab 1 gm IV on Treatment Day 168 * Rituximab 1 gm IV on Treatment Day 182

ACE/ARBdrug

ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of \<130/80 millimeters of mercury (mmHg). Patients not attaining the target blood pressure with an ACE inhibitor or ARB alone should be treated with the combination of ACE inhibitor (ACEi) + ARB

Omega-3 Fatty Acid Fish Oil Supplementdietary

Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day