Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Summary

A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.

Conditions

• IgA Nephropathy

Interventions

DRUG

irbesartan

In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( \< 5 g NaCl/day), and then given a stable dose (150mg \~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.

DRUG

methylprednisolone (MP) or prednisone (pred)

Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.

DRUG

mycophenolate mofetil (MMF)

Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt \< 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Xueqing Yu, MD · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

• Yunha Liao, MD · Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University,Guangxi

• Jinli Zhang, MD · Department of nephrology, People's Hospital of Yunnan Province

• Junzhou Fu, MD · Department of Nephrology,1st People's Hospital of Guangzhou

• Anping Xu, MD · Department of Nephrology, 2nd Affiliated Hospital of Sun Yet-Sen University,Guangzhou

• Zhangsuo liu, MD · Department of Nephrology, 1st Affiliated hospital of Zhengzhou University, Henan

• Tanqi lou, MD · Department of Nephrology, 3nd affiliated hospital of Sun yatsent university, Guangzhou

• Li Hao, MD · Department of Nephrology, 2nd Affiliated Hospital of Anhui Medical University, Anhui

• Menghua Chen, MD · Department of Nephrology, General Hospital of Ningxia Medical University, Ningxia

• Qinkai Chen, MD · Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• China

Study Locations