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Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

NCT00498368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-02-01

Study results available
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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.

Conditions

Interventions

DRUG

Intravenous Rituximab

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

DRUG

ACE/ARB

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

DIETARY_SUPPLEMENT

Omega-3 Fatty Acid Fish Oil Supplement

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

Sponsors & Collaborators

Principal Investigators

  • Fernando C. Fervenza, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00498368 on ClinicalTrials.gov