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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

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.

Interventions

  • 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
  • Drug: ACE inhibitor
    • maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
  • Drug: Corticosteroid
    • combination with Mycophenolate Mofetil
  • Drug: ARB
    • maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization

Arms, Groups and Cohorts

  • Experimental: Mycophenolate Mofetil
    • MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
  • Active Comparator: Conservative treatment
    • maintain conservative treatment (ACE inhibitor or ARB)

Clinical Trial Outcome Measures

Primary Measures

  • Remission rate (complete / partial)
    • Time Frame: up to 48 weeks

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Collaborator
    • Chong Kun Dang Pharmaceutical Corp.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Beom Seok Kim, Professor – Yonsei University
  • Overall Official(s)
    • BEOMSUK KIM, Principal Investigator, Severance Hospital
  • Overall Contact(s)
    • EUNJU JUNG, 82-10-5414-7760, oakly74@nate.com

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