Rituxan in Churg Strauss Syndrome With Renal Involvement

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Fernando Fervenza
Study ID
NCT00424749
Phase
PHASE2
Status
Terminated

Conditions

  • Churg-Strauss Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Patients received 4 weekly doses of rituximab 375 mg/m\^2.
  • Prednisone — DRUG
    Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months

Study Details

Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.

Key Dates

Start date
Jun 30, 2007
Status verified
Nov 2011
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    375 mg/m\^2/week for 4 weeks

Primary Outcome Measure

Participants With Remission of Renal Disease Activity at 3 Months [ Time Frame: 3 months after beginning of remission induction regimen ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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