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

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ClinicalTrials.gov Identifier: NCT02981212
Recruitment Status : Unknown
Verified November 2016 by Beom Seok Kim, Yonsei University.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Chong Kun Dang Pharmaceutical Corp.
Kyung Hee University Hospital at Gangdong
Kyungpook National University Hospital
Pusan National University Yangsan Hospital
Inje University
Seoul St. Mary's Hospital
Chonbuk National University Hospital
Information provided by (Responsible Party):
Beom Seok Kim, Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Mycophenolate Mofetil Drug: ACE inhibitor Drug: Corticosteroid Drug: ARB Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mycophenolate Mofetil
MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
 Drug: 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
Other Name: MYREPT®

Drug: Corticosteroid
combination with Mycophenolate Mofetil
Other Names:
  • prednisolone
  • methyprednisolone
Active Comparator: Conservative treatment
maintain conservative treatment (ACE inhibitor or ARB)
 Drug: ACE inhibitor
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Other Name: conservative treatment

Drug: ARB
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
Other Name: conservative treatment


Outcome Measures
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Primary Outcome Measures :
  1. Remission rate (complete / partial) [ Time Frame: up to 48 weeks ]

Secondary Outcome Measures :
  1. Remission rate (complete / partial) [ Time Frame: at 12 weeks, at 24 weeks, at 36 weeks ]
  2. eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease) [ Time Frame: at 24 weeks, at 36 weeks, at 48 weeks ]
  3. The incidence of renal replacement therapy [ Time Frame: up to 48 weeks ]
    renal replacement therapy; dialysis, new transplant

  4. The average time to occurrence of renal replacement therapy [ Time Frame: up to 48 weeks ]
    renal replacement therapy; dialysis, new transplant


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patient aged 19 to 65 years old
  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:

  1. If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981212


Contacts
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Contact: EUNJU JUNG 82-10-5414-7760 oakly74@nate.com
Contact: JONGHYUK LEE 82-10-5599-1199 leejongh@ckdpharm.com

Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: EUNU JUNG    82-10-5414-7760    oakly74@nate.com   
Principal Investigator: CHANDUK KIM, PhD         
Principal Investigator: DONGWON LEE, PhD         
Principal Investigator: SANGHO LEE, PhD         
Principal Investigator: BUMSOON CHOI, PhD         
Principal Investigator: SANGYEOB HAN, PhD         
Principal Investigator: SIK LEE, PhD         
Sponsors and Collaborators
Yonsei University
Chong Kun Dang Pharmaceutical Corp.
Kyung Hee University Hospital at Gangdong
Kyungpook National University Hospital
Pusan National University Yangsan Hospital
Inje University
Seoul St. Mary's Hospital
Chonbuk National University Hospital
Investigators
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Principal Investigator: BEOMSUK KIM Severance Hospital
More Information
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Responsible Party: Beom Seok Kim, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02981212    
Other Study ID Numbers: 062IGA15-1D
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisolone
Angiotensin-Converting Enzyme Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
 Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Protease Inhibitors