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Trial record 2 of 5 for:    "Churg-Strauss Syndrome" | "glucocorticoids"

Rituxan in Churg Strauss Syndrome With Renal Involvement

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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
Sponsor:
Collaborators:
Genentech, Inc.
Biogen
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 19, 2007
First Posted Date  ICMJE January 22, 2007
Results First Submitted Date  ICMJE September 12, 2011
Results First Posted Date  ICMJE December 8, 2011
Last Update Posted Date December 8, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
  • Safety of Rituximab in patients with Churg-Strauss
  • Remission of renal disease activity as 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 is smalle
Change History Complete list of historical versions of study NCT00424749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
Normalization of eosinophil count at six months. Normalization is defined as total eosinophil counts <1.5 x 109/l.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituxan in Churg Strauss Syndrome With Renal Involvement
Official Title  ICMJE A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Churg-Strauss Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Rituximab
375 mg/m^2/week for 4 weeks
Interventions:
  • Drug: Rituximab
  • Drug: Prednisone
Publications * Cartin-Ceba R, Keogh KA, Specks U, Sethi S, Fervenza FC. Rituximab for the treatment of Churg-Strauss syndrome with renal involvement. Nephrol Dial Transplant. 2011 Sep;26(9):2865-71. doi: 10.1093/ndt/gfq852. Epub 2011 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2011)
4
Original Enrollment  ICMJE
 (submitted: January 19, 2007)
5
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00424749
Other Study ID Numbers  ICMJE 06-004767
UL1RR024150 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Fervenza, Mayo Clinic
Study Sponsor  ICMJE Fernando Fervenza
Collaborators  ICMJE
  • Genentech, Inc.
  • Biogen
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP