A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Overview
- Phase
- Phase 3
- Intervention
- irbesartan
- Conditions
- IgA Nephropathy
- Sponsor
- Sun Yat-sen University
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Remission of proteinuria (complete or partial)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Xue Qing Yu
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Willingness to sign an informed consent
- •Age:14\~60 years, regardless of gender
- •Clinical evaluation and renal biopsy diagnostic for IgAN, excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
- •1 g/day \<= proteinuria \< 3.5 g/day, or UPr/Cr ratio ≥ 0.6 (male) or ≥ 0.8 (female) when taking ARB
- •eGFR ≥ 40 mL/min/1.73 m2
Exclusion Criteria
- •Inability or unwillingness to sign the informed consent
- •Inability or unwillingness to meet the scheme demands raised by the investigators
- •Rapidly progressive nephritic syndrome and acute renal failure, including rapidly progressive IgAN ( IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
- •Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
- •est GFR \< 40 mL/min/1.73m2
- •Malignant hypertension that is difficult to be controlled by oral drugs
- •Cirrhosis, chronic active liver disease.
- •History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.)
- •Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
- •Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
Arms & Interventions
Pred group
Pred Group: Prednisone treatment Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.
Intervention: irbesartan
Pred group
Pred Group: Prednisone treatment Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.
Intervention: methylprednisolone (MP) or prednisone (pred)
MMF Group
MMF Group: MMF treatment 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 0.5 bid for the remaining 6-month.
Intervention: irbesartan
MMF Group
MMF Group: MMF treatment 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 0.5 bid for the remaining 6-month.
Intervention: mycophenolate mofetil (MMF)
Pred plus MMF Group
Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month. 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 0.5 bid for the remaining 6-month.
Intervention: irbesartan
Pred plus MMF Group
Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month. 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 0.5 bid for the remaining 6-month.
Intervention: methylprednisolone (MP) or prednisone (pred)
Pred plus MMF Group
Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month. 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 0.5 bid for the remaining 6-month.
Intervention: mycophenolate mofetil (MMF)
Outcomes
Primary Outcomes
Remission of proteinuria (complete or partial)
Time Frame: up to 4.3 years
Secondary Outcomes
- Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation)(every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）)