Rituxan in Churg Strauss Syndrome With Renal Involvement

Churg-Strauss Syndrome Clinical Trial

Official title:

A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00424749
• Other study ID #: 06-004767
• Secondary ID: UL1RR024150
• Status: Terminated
• Phase: Phase 2
• First received: January 19, 2007
• Last updated: November 3, 2011
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Syndrome

Intervention

Drug:
• Rituximab
Patients received 4 weekly doses of rituximab 375 mg/m^2.
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Fernando Fervenza	Biogen, Genentech, Inc., National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Remission of Renal Disease Activity at 3 Months	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)	3 months after beginning of remission induction regimen	No
Secondary	Participants With Normalization of Eosinophil Count at 6 Months	Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.	6 months after beginning of remission induction regimen	No

External Links

•   Mayo Clinic Clinical Trials