We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Rituxan in Churg Strauss Syndrome With Renal Involvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00424749
Recruitment Status : Terminated (Company providing study drug terminated study due to lack of funds)
First Posted : January 22, 2007
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Genentech, Inc.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Churg-Strauss Syndrome Drug: Rituximab Drug: Prednisone Phase 2

Detailed Description:
Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement
Study Start Date : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: Rituximab
375 mg/m^2/week for 4 weeks
Drug: Rituximab
Patients received 4 weekly doses of rituximab 375 mg/m^2.
Other Names:
  • Rituxan
  • MabThera

Drug: Prednisone
Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months
Other Names:
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
  • Prednicen-M
  • Prednicot
  • Sterapred
  • Sterapred DS

Primary Outcome Measures :
  1. Participants With Remission of Renal Disease Activity at 3 Months [ Time Frame: 3 months after beginning of remission induction regimen ]
    Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)

Secondary Outcome Measures :
  1. Participants With Normalization of Eosinophil Count at 6 Months [ Time Frame: 6 months after beginning of remission induction regimen ]
    Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Churg-Strauss syndrome as defined by meeting one of 3 sets of criteria for Churg-Strauss Syndrome described above who have not yet been treated, who have failed steroid therapy (partial or non-responders) or who can not been tapered off oral prednisone because of documented relapsing disease
  • Renal involvement (>25% dysmorphic red cell, red blood cell casts, or pauci-immune glomerulonephritis on biopsy)
  • Age >18 years old
  • Serum creatinine less than or equal to 3.0 mg/dl
  • Able and willing to give written informed consent and comply with the requirements of the study protocol.
  • Negative serum pregnancy test (for women of child bearing age)
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.

Exclusion Criteria

  • Severe obstructive or restrictive lung disease (forced expiratory volume in one second <1)
  • Cerebral involvement
  • Rapidly progressive optic neuropathy or retinal vasculitis
  • Active gastrointestinal bleeding
  • Heart failure, including pericarditis or myocarditis.
  • Hemoglobin <8.5 gm/dL
  • Platelets <100,000/mm
  • AST or ALT >2.5 Upper Limit of Normal unless related to primary disease
  • Positive Hepatitis B or C serology
  • History of positive HIV testing
  • Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
  • Previous treatment with Rituximab
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of recurrent significant infection or history of recurrent bacterial infections
  • Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
  • Lack of peripheral venous access
  • History of drug, alcohol, or chemical abuse within 6 months prior to screening
  • Pregnancy or lactation
  • Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424749

Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Fernando Fervenza
Genentech, Inc.
National Center for Research Resources (NCRR)
Layout table for investigator information
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D. Mayo Clinic
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Fernando Fervenza, MD, PhD, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00424749    
Other Study ID Numbers: 06-004767
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2007    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011
Last Verified: November 2011
Keywords provided by Fernando Fervenza, Mayo Clinic:
Antineutrophil cytoplasmic antibody associated vasculitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Churg-Strauss Syndrome
Pathologic Processes
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal