NCT00657059

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

A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study. Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2008-04-14
• Last updated: 2019-12-03

Locations

1 site across 1 country: China