Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Collaborators: Chengdu Women and Children's Center Hospital; Children's Hospital of Fudan University; First Affiliated Hospital of Zhongshan Medical University; Nanjing Children's Hospital; Peking University First Hospital; Second Xiangya Hospital of Central South University; Tongji Hospital
• Treatments: Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Sensitive but frequent relapses or steroids dependence nephrotic syndrome

• Age: 2 to 18 years old

• Normal renal function: estimated glomerular filtration rate ≥90ml/min/1.73m2

• Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll

• No tacrolimus, mycophenolate mofetil, cyclosporine A, rituximab or cyclophosphamide was used within 2 years prior to the enrollment

Exclusion Criteria:

• steroids-resistant nephrotic syndrome

• Family history of nephrotic syndrome, chronic glomerulonephritis or uremia

• Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)

• Moderate to severe anemia (hemoglobin <9.0 g/dL)

• Thrombocytopenia (platelet count <100*10^12/L)

• Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)

• There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness

• Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)

• Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney

• Those who with other autoimmune diseases or primary immunodeficiencies or tumors

• Those who was known to be sensitized to tacrolimus, mycophenolate mofetil, glucocorticoids, or any of the above drugs

• Those who have participated in other clinical trials within three months prior to the enrollment

• Those who was not suitable for participating this study judged by investigator