Mycophenolate mofetil for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial(JSKDC07)
- Conditions
- Childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome
- Registration Number
- JPRN-UMIN000014347
- Lead Sponsor
- Japanese Study Group of Kidney Disease in Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1.Patients who have been diagnosed with nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected. 2.Patients meeting either one of the following infection: 1) Presence or history of severe infections within 6 months prior to assignment. 2) Presence or history of opportunistic infections within 6 months prior to assignment. 3) Presence of active tuberculosis. 4) Patients with a history of tuberculosis or in whom tuberculosis is suspected. 5) Presence or history of active Hepatitis B or Hepatitis C or hepatitis B virus carrier. 6) Presence of HIV infection. 3.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG. 4.Presence or history of auto-immune diseases or vascular purpura. 5.Presence or history of malignant tumor. 6.History of organ transplantation. 7.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate. 8.Uncontrollable hypertension. 9.Deteriorated kidney function, e.g. estimated GFR<60 mL/min./1.73m2. 10.Having received a live vaccine within 4 weeks prior to enrollment. 11.Patients showing either one of the following abnormal clinical laboratory value: 1)WBC <3,000/microL. 2)neutrophil <1,500/microL. 3)PLT <50,000/microL. 4)ALT >2.5 x upper limit of normal value. 5)AST >2.5 x upper limit of normal value. 6)Positive for HBs antigen, HBs antibody, HBc antibody and HCV antibody. 7)Positive for HIV antibody. 12.Patients who do not agree with contraception during the study period. 13.Women during pregnancy or breast-feeding. 14.Judged inap.propriate for this study by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The time to treatment failure
- Secondary Outcome Measures
Name Time Method Relapse free period, Time to SDNS, Time to FRNS, Time to SRNS, B cell depletion period, Daily steroid dose