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

Phase 4

• Conditions: IgA Nephropathy
• Interventions: Drug: ACE inhibitor; Drug: Mycophenolate Mofetil; Drug: Corticosteroid; Drug: ARB

• Registration Number: NCT02981212
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-30
• Last Update Submitted: 2016-11-30
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-05
• Primary Completion: 2018-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate Mofetil	Corticosteroid	MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
Conservative treatment	ACE inhibitor	maintain conservative treatment (ACE inhibitor or ARB)
Conservative treatment	ARB	maintain conservative treatment (ACE inhibitor or ARB)
Mycophenolate Mofetil	Mycophenolate Mofetil	MYREPT® capsule(CKDpharm, KOREA) and corticosteroid

Primary Outcome Measures

Name	Time	Method
Remission rate (complete / partial)	up to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Remission rate (complete / partial)	at 12 weeks, at 24 weeks, at 36 weeks
eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)	at 24 weeks, at 36 weeks, at 48 weeks
The incidence of renal replacement therapy	up to 48 weeks	renal replacement therapy; dialysis, new transplant
The average time to occurrence of renal replacement therapy	up to 48 weeks	renal replacement therapy; dialysis, new transplant

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of