Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome
Condition: Nephrotic Syndrome in Children
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic
      syndrome in childhood and it is the most common glomerular disease in children. Although
      treatment with steroids is uesful for primary nephrotic syndrome, proning to cause frequent
      relapse/steroid-dependent nephrotic syndrome after treatment, and the usage of
      immunosuppressive agents has become a new choice for the treatment of such patients. This
      study is a prospective, randomized, multicenter, open, parallel controlled trial, evaluating
      the efficacy and safety of steroid combined with the immunosuppressive agents which are
      tacrolimus and mycophenolate mofetil to children who with frequently relapsing or
      steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and
      individualized treatment options for children with nephrotic syndrome.
    

Detailed description: 
      Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast
      majority of children relapse, and about half of them have frequent relapse or steroids
      dependence after treatment with steroids alone. Some children experienced steroids-resistance
      after multiple relapses, and eventually developed into chronic kidney dysfunction. Long-term
      or repeated application of large doses of steroids will lead to side effects such as obesity,
      growth retardation, and hypertension. Although the treatment of steroids with
      immunosuppressive agents is a new choice for the treatment of such patients, traditional
      immunosuppressive agents such as cyclophosphamide and cyclosporine A will bring some serious
      irreversible side effects, while immunosuppressive agents tacrolimus has the dual effects of
      immunosuppression and podocyte protection, and is more widely used in the department of
      nephrology, what's more, the other immunosuppressive agents mycophenolate mofetil has
      advantage of no kidney toxic, less adverse reactions and higher safety, which gradually being
      valued by nephrologists in recent years. This study mainly compares the efficacy and safety
      of tacrolimus and mycophenolate mofetil in the treatment of children with frequently
      relapsing or steroids-dependent nephrotic syndrome, in order to provide a more effective and
      safer treatment for children with nephrotic syndrome as well as the therapeutic medication
      options.
    

Intervention name(s): Tacrolimus; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is < 5ng/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.; The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20~30mg/kg/day，BID. The concentration for MPA-AUC is 30~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year.
Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day.
Other intervention name(s): Tacrolimus capsules（CYONSE®）; Mycophenolate Mofetil Dispersible tablets（CYCOPIN®）
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephrotic Syndrome; Frequently Relapsing Nephrotic Syndrome; Steroid Dependent Nephrotic Syndrome; Tacrolimus; Mycophenolate mofetil