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

This study is currently recruiting participants.
Verified November 2016 by Beom Seok Kim, Yonsei University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981212
First Posted: December 5, 2016
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Chong Kun Dang Pharmaceutical Corp.
Kyung Hee University Hospital at Gangdong
Kyungpook National University
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
  Purpose
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 Intervention Phase
IgA Nephropathy Drug: Mycophenolate Mofetil Drug: ACE inhibitor Drug: Corticosteroid Drug: ARB Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beom Seok Kim, Yonsei University:

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

Secondary Outcome Measures:
  • 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 [ Time Frame: up to 48 weeks ]
    renal replacement therapy; dialysis, new transplant

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


Estimated Enrollment: 100
Study Start Date: June 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (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
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
Contact: EUNJU JUNG 82-10-5414-7760 oakly74@nate.com
Contact: JONGHYUK LEE 82-10-5599-1199 leejongh@ckdpharm.com

Locations
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
Pusan National University Yangsan Hospital
Inje University
Seoul St. Mary's Hospital
Chonbuk National University Hospital
Investigators
Principal Investigator: BEOMSUK KIM Severance Hospital
  More Information

Responsible Party: Beom Seok Kim, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02981212     History of Changes
Other Study ID Numbers: 062IGA15-1D
First Submitted: November 24, 2016
First Posted: December 5, 2016
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:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
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
Protease Inhibitors