The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated. The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance. The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
combination with Mycophenolate Mofetil
Severance Hospital
Seoul, South Korea
RECRUITINGRemission rate (complete / partial)
Time frame: up to 48 weeks
Remission rate (complete / partial)
Time frame: at 12 weeks, at 24 weeks, at 36 weeks
eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)
Time frame: at 24 weeks, at 36 weeks, at 48 weeks
The incidence of renal replacement therapy
renal replacement therapy; dialysis, new transplant
Time frame: up to 48 weeks
The average time to occurrence of renal replacement therapy
renal replacement therapy; dialysis, new transplant
Time frame: up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization