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

November 30, 2016 updated by: Beom Seok Kim, Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • conservative treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate (complete / partial)
Time Frame: at 12 weeks, at 24 weeks, at 36 weeks
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
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
up to 48 weeks
The average time to occurrence of renal replacement therapy
Time Frame: up to 48 weeks
renal replacement therapy; dialysis, new transplant
up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Chonbuk National University Hospital
Seoul St. Mary's Hospital
Kyungpook National University Hospital
Inje University
Kyung Hee University Hospital at Gangdong
Pusan National University Yangsan Hospital
Chong Kun Dang Pharmaceutical Corp.

Investigators

  • Principal Investigator: BEOMSUK KIM, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062IGA15-1D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IgA Nephropathy

Clinical Trials on Mycophenolate Mofetil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe