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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Yonsei University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Remission rate (complete / partial)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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
Arms & Interventions
Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
Intervention: Mycophenolate Mofetil (Drug)
Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
Intervention: Corticosteroid (Drug)
Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
Intervention: ACE inhibitor (Drug)
Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
Intervention: ARB (Drug)
Outcomes
Primary Outcomes
Remission rate (complete / partial)
Time Frame: up to 48 weeks
Secondary Outcomes
- 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(up to 48 weeks)
- The average time to occurrence of renal replacement therapy(up to 48 weeks)
Investigators
Beom Seok Kim
Professor
Yonsei University