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

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

May 31, 2019

Study Completion Date

May 31, 2019

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.

Trial Locations (1)

510080

The 1st Affiliated Hospital, Sun Yet-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT00657059 - Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) | Biotech Hunter | Biotech Hunter