Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
This trial is active, not recruiting.
|Treatments||irbesartan, methylprednisolone (mp) or prednisone (pred), mycophenolate mofetil (mmf)|
|Sponsor||Sun Yat-sen University|
|Start date||September 2007|
|End date||April 2017|
|Trial size||151 participants|
|Trial identifier||NCT00657059, SYSU-PRGIgAN-001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Remission of proteinuria (complete or partial)
time frame: up to 4.3 years
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)
time frame: every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）
Male or female participants from 14 years up to 60 years old.
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) - Malignant tumors (except fully cured basal cell carcinoma) - Absolute neutrophil count ＜ 1500／mm3, absolute platelet count ＜75000／mm3 or hematocrit (Hct) <28% (anemic subjects may be reevaluated after the anemia has been treated.) - Known allergy, contraindication or intolerance to the MMF, corticosteroids or ACEI/ARB. - Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception - Current exposure to MMF or azathioprine. In case of current treatment with oral steroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stopped for 2 weeks. - Current or recent (within 30 days) exposure to any other investigational drugs
|Official title||A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)|
|Principal investigator||Xueqing Yu, MD|
|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.|
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