Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy

Part of paid clinical trials in San Francisco, California.

Sponsor
Mayo Clinic
Study ID
NCT00498368
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravenous Rituximab — DRUG
    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/ARB — DRUG
    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 Supplement — DIETARY_SUPPLEMENT
    Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day

Study Details

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.

Key Dates

Start date
Feb 28, 2009
Status verified
Dec 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Plus ACE/ARB
    Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement
  • Active Comparator: ACE/ARB
    ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement

Primary Outcome Measure

Change in Proteinuria at 12 Months [ Time Frame: 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford UniversitySan FranciscoCalifornia94304-
Mayo ClinicRochesterMinnesota55905-
Columbia University Medical CenterNew YorkNew York10032-
University of North Carolina, Chapel HillChapel HillNorth Carolina27599-
The University of OhioColumbusOhio43210-1063-

Find similar trials in San Francisco, CA

By research site
Stanford University· San Francisco, CAMayo Clinic· Rochester, MNColumbia University Medical Center· New York, NYUniversity of North Carolina, Chapel Hill· Chapel Hill, NCThe University of Ohio· Columbus, OH

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