Double-Blind Study of IDEC-C2B8 in Patients with Childhood-onset Complicated FRNS or SDNS - RCRNS01

Kobe University Hospital0 sites60 target enrollmentSeptember 19, 2008

ConditionsChildhood-onset Complicated Nephrotic Syndrome

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Childhood-onset Complicated Nephrotic Syndrome
Sponsor: Kobe University Hospital
Enrollment: 60
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

We have shown that the relapse-free period increases with rituximab in patients with childhood-onset, complicated FRNS and SDNS. Adverse events were generally mild and the frequency of serious adverse events did not differ significantly between groups. Rituximab is an effective and safe treatment for childhood-onset, complicated FRNS and SDNS.

Registry

who.int

Start Date

September 19, 2008

End Date

December 27, 2013

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kobe University Hospital

Eligibility Criteria

Inclusion Criteria

•1\. Diagnosed as idiopathic nephrotic syndrome (INS) according to the ISKDC criteria.
•2\. Subjects meeting either one of the following criteria:
•1\) Diagnosed as frequently relapsing or steroid\-dependent INS again after immunosuppressant treatment such as cyclosporine A, cyclophosphamide and/or mizoribine for previous frequently relapsing or steroid\-dependent NS.
•2\) Diagnosed as frequently relapsing or steroid\-dependent INS during immunosuppressant treatment such as cyclosporine A, cyclophosphamide and/or mizoribine for previous frequently relapsing or steroid\-dependent NS.
•3\) Diagnosed as frequently relapsing or steroid\-dependent INS after or during treatment with cyclosporine A alone or in combination with methylprednisolone for previous steroid\-resistant NS which was initially diagnosed as NS.
•3\. First onset of INS is between 1 \- 18 years of age, and 2 years of age or older at entry.
•4\. Subjects with records of nearest preceding 3 relapses
•5\. Diagnosed as steroid\-sensitive relapse
•6\.CD20 positive B\-cells \>/\= 5/mcL in the peripheral blood
•7\. Subjects can be hospitalized for treatments

Exclusion Criteria

•1\. History of inflammatory nephritis such as IgA nephritis.
•2\. History of immunosuppressive treatment for INS other than cyclosporine A, cyclophosphamide, mizoribine, mycophenolate mofetil and chlorambucil
•3\. History of serious infectious diseases such as pulmonary tuberculosis and deep\-seated fungal diseases
•4\. Positive for HCV antibody, HBs antigen, HBc antibody and HIV antibody
•5\. Having received a live vaccine within 4 weeks prior to screening
•6\.Known hypertension which is uncontrollable with conventional anti\-hypertensive
•7\. Deteriorated kidney function, e.g. estimated GFR\<60mL/min./1\.73m2
•8\. Deteriorated liver function, e.g., AST or ALT \> 2\.5 x upper limit of normal value
•9\. Presence or history of angina pectoris, cardiac failure, myocardial infarction and/or serious arrhythmia grade 4 in Common Terminology Criteria for Adverse Events (ver. 3\.0\)
•10\. Presence or history of auto\-immune diseases such as Hashimoto disease (struma lymphomatosa), Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma or vascular purpura