Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Mycophenolate Mofetil
* Drug: ACE inhibitor
* Drug: Corticosteroid
* Drug: ARB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient aged 19 to 65 years old Diagnosed with IgA nephropathy Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2 ACE inhibitor or ARB for at least 3 months Willing and able to provide written informed consent. Exclusion Criteria: If eGFR (by MDRD) is <15 mL / min / 1.73 m^2 Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer) serious digestive disorder WBC <3000 / mm^3 Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs Administration of other Investigational drugs within 28days before screening period Administration of Investigator drug or other immunosuppressants within 84days before screening period Women in pregnant or breast-feeding or don't using adequate contraception. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc. In investigator's judgment

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycophenolate Mofetil<br>MYREPT® capsule(CKDpharm, KOREA) and corticosteroid | Drug: Mycophenolate Mofetil<br>* less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally<br>* Other names: MYREPT®;Drug: Corticosteroid<br>* combination with Mycophenolate Mofetil<br>* Other names: methyprednisolone;|
| Active Comparator: Conservative treatment<br>maintain conservative treatment (ACE inhibitor or ARB) | Drug: ACE inhibitor<br>* maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization<br>* Other names: conservative treatment;Drug: ARB<br>* maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization<br>* Other names: conservative treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (complete / partial) |  | up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (complete / partial) |  | at 12 weeks, at 24 weeks, at 36 weeks | 
| eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease) |  | at 24 weeks, at 36 weeks, at 48 weeks | 
| The incidence of renal replacement therapy | renal replacement therapy; dialysis, new transplant | up to 48 weeks | 
| The average time to occurrence of renal replacement therapy | renal replacement therapy; dialysis, new transplant | up to 48 weeks |