Rituxan in Churg Strauss Syndrome With Renal Involvement

NCT00424749 | Terminated Phase 2 Results DMC

• 2 other identifiers: 06-004767UL1RR024150
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Churg-Strauss Syndrome

Keywords

Antineutrophil cytoplasmic antibody associated vasculitis; Glomerulonephritis; Rituximab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Participants With Normalization of Eosinophil Count at 6 Months

  6 months after beginning of remission induction regimen

Study Arms (1)

Rituximab

EXPERIMENTAL

375 mg/m\^2/week for 4 weeks

Drug: Rituximab; Drug: Prednisone

Interventions

Rituximab DRUG

Patients received 4 weekly doses of rituximab 375 mg/m\^2.

Also known as: Rituxan, MabThera

Rituximab

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

Also known as: Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fernando Fervenza: lead
• Genentech, Inc.: collaborator
• Biogen: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

  PMID: 21325353 RESULT

MeSH Terms

Conditions

Churg-Strauss Syndrome; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Glomerulonephritis

Interventions

Rituximab; Prednisone

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The limited number of individuals enrolled into the study makes it difficult to draw firm conclusions that are more than hypothesis generating. The company providing study drug terminated study due to lack of funds.

Results Point of Contact

• Title: Dr. Fernando C. Fervenza
• Organization: Mayo Clinic

fervenza.fernando@mayo.edu

Study Officials

• Fernando C. Fervenza, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Professor of Medicine

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 22, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 8, 2011
• Results First Posted: December 8, 2011

Record last verified: 2011-11

Locations

US (1)