nephrotic syndrome
Conditions
Interventions
The experimental group is Levamisole group: Oral levamisole
the control group is mycomycophenolate group:Oral mycomycophenolate
Sponsors
Henan Children's Hospital
Children's Hospital of Zhengzhou University
Henan Children's Hospital Zhengzhou Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) The age of first onset was 1 to 18 years old; (2) Diagnosis of primary nephrotic syndrome according to the Evidence-Based Guidelines for the Diagnosis and Treatment of Hormone-Sensitive, Relapsing/Dependent Nephrotic Syndrome in Children (2016); (3) Meet the diagnostic criteria of hormone sensitivity (=4 weeks of adequate glucocorticoid therapy for urine protein conversion); (4) Meet the diagnostic criteria of frequent relapses (=2 relapses within 6 months or =4 relapses within 1 year during the course of the disease); (5) Meet the diagnostic criteria of hormone dependence (sensitive to hormones, but relapse within 2 weeks after two consecutive dose reductions or drug cessation); (6) Normal renal function at the time of enrollment: glomerular filtration rate (eGFR ) = 90ml/min/1.73m2; (7) Voluntary enrollment in the study and signing of informed consent, children under 18 years of age were signed by their guardians.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with hormone-resistant nephrotic syndrome; (2) Patients with contraindications to rituximab, mortimecoxib, and levamisole; (3) Patients with known secondary nephrotic syndrome (e.g., associated glomerulonephritis due to systemic lupus erythematosus, anaphylactic purpura, hepatitis B virus, EB virus, cytomegalovirus (CMV), and other infections); (4) Patients with active chronic infections (tuberculosis, HIV, hepatitis B or C); (5) Patients with live vaccination within 1 month prior to enrollment; (6) Patients with severe leukopenia (leukocytes <3.0×1000 cells/mm^3), severe anemia (hemoglobin <8.9 g/dl), and thrombocytopenia (platelets <10.00×1000 cells/mm^3); (7) Patients with abnormal liver function (AST or ALT to =50 IU/L); (8) Patients with comorbidities such as other autoimmune diseases, primary immunodeficiencies, tumors, diabetes mellitus, primary hypertension, congenital heart disease, and psychiatric disorders; (9) Patients previously treated with monoclonal antibodies other than rituximab; (10) Patients who have used rituximab within the past 1 year; (11) Patients who are participating in a clinical trial of another drug; (12) Patients deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of recurrences within one year of follow-up for patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first recurrence;cumulative use of glucocorticoids during follow-up period;Cumulative number of hospitalizations;Maintenance of mitigation rates; | — |
Countries
China
Contacts
Public ContactLiu Cuihua
Henan Children's Hospital Children's Hospital of Zhengzhou University Henan Children's Hospital Zhengzhou Children's Hospital
Outcome results
None listed