Clinical trial NCT02981212: Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IgA Nephropathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical Corp.
name: Kyung Hee University Hospital at Gangdong
name: Kyungpook National University Hospital
name: Pusan National University Yangsan Hospital
name: Inje University
name: Seoul St. Mary's Hospital
name: Chonbuk National University Hospital
First posted: 2016-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Remission rate (complete / partial)
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Remission rate (complete / partial)
timeFrame: at 12 weeks, at 24 weeks, at 36 weeks
measure: eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)
timeFrame: at 24 weeks, at 36 weeks, at 48 weeks
measure: The incidence of renal replacement therapy
timeFrame: up to 48 weeks
measure: The average time to occurrence of renal replacement therapy
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: BEOMSUK KIM
role: PRINCIPAL_INVESTIGATOR
References: