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

Primary Purpose

IgA Nephropathy

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Mycophenolate Mofetil

ACE inhibitor

Corticosteroid

ARB

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patient aged 19 to 65 years old
Diagnosed with IgA nephropathy
Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2
ACE inhibitor or ARB for at least 3 months
Willing and able to provide written informed consent.

Exclusion Criteria:

If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg
Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
serious digestive disorder
WBC <3000 / mm^3
Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
Administration of other Investigational drugs within 28days before screening period
Administration of Investigator drug or other immunosuppressants within 84days before screening period
Women in pregnant or breast-feeding or don't using adequate contraception.
Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
In investigator's judgment

Sites / Locations

Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mycophenolate Mofetil

Conservative treatment

Arm Description

MYREPT® capsule(CKDpharm, KOREA) and corticosteroid

maintain conservative treatment (ACE inhibitor or ARB)

Outcomes

Primary Outcome Measures

Remission rate (complete / partial)

Secondary Outcome Measures

Remission rate (complete / partial)

eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)

The incidence of renal replacement therapy

renal replacement therapy; dialysis, new transplant

The average time to occurrence of renal replacement therapy

renal replacement therapy; dialysis, new transplant

Full Information

NCT ID

NCT02981212

First Posted

November 24, 2016

Last Updated

November 30, 2016

Sponsor

Yonsei University

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

1. Study Identification

Unique Protocol Identification Number

NCT02981212

Brief Title

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

Acronym

AIGA

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yonsei University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgA Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mycophenolate Mofetil

Arm Type

Experimental

Arm Description

MYREPT® capsule(CKDpharm, KOREA) and corticosteroid

Arm Title

Conservative treatment

Arm Type

Active Comparator

Arm Description

maintain conservative treatment (ACE inhibitor or ARB)

Intervention Type

Drug

Intervention Name(s)

Mycophenolate Mofetil

Other Intervention Name(s)

MYREPT®

Intervention Description

less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally

Intervention Type

Drug

Intervention Name(s)

ACE inhibitor

Other Intervention Name(s)

conservative treatment

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Corticosteroid

Other Intervention Name(s)

prednisolone, methyprednisolone

Intervention Description

combination with Mycophenolate Mofetil

Intervention Type

Drug

Intervention Name(s)

ARB

Other Intervention Name(s)

conservative treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Remission rate (complete / partial)

Time Frame

up to 48 weeks

Secondary Outcome Measure Information:

Title

Remission rate (complete / partial)

Time Frame

at 12 weeks, at 24 weeks, at 36 weeks

Title

eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)

Time Frame

at 24 weeks, at 36 weeks, at 48 weeks

Title

The incidence of renal replacement therapy

Description

renal replacement therapy; dialysis, new transplant

Time Frame

up to 48 weeks

Title

The average time to occurrence of renal replacement therapy

Description

renal replacement therapy; dialysis, new transplant

Time Frame

up to 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patient aged 19 to 65 years old Diagnosed with IgA nephropathy Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2 ACE inhibitor or ARB for at least 3 months Willing and able to provide written informed consent. Exclusion Criteria: If eGFR (by MDRD) is <15 mL / min / 1.73 m^2 Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer) serious digestive disorder WBC <3000 / mm^3 Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs Administration of other Investigational drugs within 28days before screening period Administration of Investigator drug or other immunosuppressants within 84days before screening period Women in pregnant or breast-feeding or don't using adequate contraception. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc. In investigator's judgment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

EUNJU JUNG

Phone

82-10-5414-7760

oakly74@nate.com

First Name & Middle Initial & Last Name or Official Title & Degree

JONGHYUK LEE

Phone

82-10-5599-1199

leejongh@ckdpharm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BEOMSUK KIM

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Severance Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

EUNU JUNG

Phone

82-10-5414-7760

oakly74@nate.com

First Name & Middle Initial & Last Name & Degree

CHANDUK KIM, PhD

First Name & Middle Initial & Last Name & Degree

DONGWON LEE, PhD

First Name & Middle Initial & Last Name & Degree

SANGHO LEE, PhD

First Name & Middle Initial & Last Name & Degree

BUMSOON CHOI, PhD

First Name & Middle Initial & Last Name & Degree

SANGYEOB HAN, PhD

First Name & Middle Initial & Last Name & Degree

SIK LEE, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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