Rituxan in Churg Strauss Syndrome With Renal Involvement

Fernando Fervenza

Status and phase

Terminated

Phase 2

Conditions

Churg-Strauss Syndrome

Treatments

Drug: Prednisone

Drug: Rituximab

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00424749

UL1RR024150 (U.S. NIH Grant/Contract)

06-004767

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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