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

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.

Conditions

• IgA Nephropathy

Interventions

DRUG

Mycophenolate Mofetil

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

DRUG

ACE inhibitor

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

DRUG

Corticosteroid

combination with Mycophenolate Mofetil

DRUG

ARB

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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical Corp.

  collaborator INDUSTRY

• Kyung Hee University Hospital at Gangdong

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Pusan National University Yangsan Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Yonsei University

  lead OTHER

Principal Investigators

• BEOMSUK KIM · Severance Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2018-08-31

Completion

2018-10-31

Countries

• South Korea

Study Locations