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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT02981212
• Date of registration: 24/11/2016
• Prospective Registration: No
• Primary sponsor: Yonsei University
• Public title: Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy AIGA
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02981212
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: EUNJU JUNG

• Name: BEOMSUK KIM
• Affiliation: Severance Hospital

• Name: EUNU JUNG

Key inclusion & 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



Age minimum: 19 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: ARB

Drug: Corticosteroid

Drug: ACE inhibitor

Drug: Mycophenolate Mofetil

Primary Outcome(s)

Remission rate (complete / partial) [Time Frame: up to 48 weeks]

Secondary Outcome(s)

The average time to occurrence of renal replacement therapy [Time Frame: up to 48 weeks]

Remission rate (complete / partial) [Time Frame: at 12 weeks, at 24 weeks, at 36 weeks]

The incidence of renal replacement therapy [Time Frame: up to 48 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]

Secondary ID(s)

062IGA15-1D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pusan National University Yangsan Hospital

Seoul St. Mary's Hospital

Chonbuk National University Hospital

Kyung Hee University Hospital at Gangdong

Chong Kun Dang Pharmaceutical Corp.

Inje University

Kyungpook National University