A phase III trial of RO5072759 in childhood onset idiopathic nephrotic syndrome patients
- Conditions
- Childhood Nephrotic Syndrome
- Registration Number
- JPRN-jRCT2011220036
- Lead Sponsor
- Will Pendergraft, M.D., Ph.D.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Diagnosis of FRNS or SDNS before the age of 18 years
-Must be in complete remission defined by the absence of edema, UPCR =< 0.2 g/g at screening, and have three consecutive daily urine dipstick readings of trace or negative for protein within the week prior to randomization
-Must have had at least one relapse in the 6 months prior to screening, after discontinuation of or while receiving oral corticosteroids and/or immunosuppressive therapy to prevent relapses
-Estimated glomerular filtration rate (eGFR) within normal range for age
-Secondary nephrotic syndrome
-History of steroid resistant nephrotic syndrome
-History of genetic defects known to directly cause nephrotic syndrome
-Treatment with other immunosuppressive medications to prevent relapse, other than MMF or oral corticosteroids within 2 months prior to randomization
-Participants demonstrating prior treatment failure to MMF as defined by two or more relapses in any 6-month period of time while receiving MMF for at least a 6-month duration
-Participants in the judgment of the investigator likely to require systemic corticosteroids for reasons other than idiopathic nephrotic syndrome during the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method