Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy
NCT ID: NCT02981212
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-06-30
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
Mycophenolate Mofetil
less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
Corticosteroid
combination with Mycophenolate Mofetil
Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
ACE inhibitor
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
ARB
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Interventions
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Mycophenolate Mofetil
less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
ACE inhibitor
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Corticosteroid
combination with Mycophenolate Mofetil
ARB
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with IgA nephropathy
3. Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
4. If eGFR (by MDRD) is \<50 mL / min / 1.73 m\^2, ≥ 15 mL / min / 1.73 m\^2
5. ACE inhibitor or ARB for at least 3 months
6. Willing and able to provide written informed consent.
Exclusion Criteria
2. Blood pressure is SBP\> 160 mmHg or DBP\> 100 mmHg
3. Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
4. serious digestive disorder
5. WBC \<3000 / mm\^3
6. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
7. Administration of other Investigational drugs within 28days before screening period
8. Administration of Investigator drug or other immunosuppressants within 84days before screening period
9. Women in pregnant or breast-feeding or don't using adequate contraception.
10. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
11. In investigator's judgment
19 Years
65 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical Corp.
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Kyungpook National University Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Inje University
OTHER
Seoul St. Mary's Hospital
OTHER
Chonbuk National University Hospital
OTHER
Yonsei University
OTHER
Responsible Party
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Beom Seok Kim
Professor
Principal Investigators
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BEOMSUK KIM
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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EUNU JUNG
Role: primary
Other Identifiers
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062IGA15-1D
Identifier Type: -
Identifier Source: org_study_id