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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: IgA Nephropathy

Treatments: Drug: ARB; Drug: Mycophenolate Mofetil; Drug: Corticosteroid; Drug: ACE inhibitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02981212

062IGA15-1D

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Mycophenolate Mofetil

Experimental group

Description:

MYREPT® capsule(CKDpharm, KOREA) and corticosteroid

Treatment:

Drug: Corticosteroid

Drug: Mycophenolate Mofetil

Conservative treatment

Active Comparator group

Description:

maintain conservative treatment (ACE inhibitor or ARB)

Treatment:

Drug: ACE inhibitor

Drug: ARB