Phase
Condition
Nephropathy
Focal Segmental Glomerulosclerosis
Nephrotic Syndrome
Treatment
Telitacicept
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil,cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was usedwithin 3 months prior to the enrollment
Exclusion
Exclusion Criteria:
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 Cvirus-positive or patients with abnormal liver function (2 or more times of alamineaminotransferase or total bilirubin was exceeded the normal value, and continued torise for 2 weeks)
There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus orMycobacterium tuberculosis, and the usage of steroids and immunosuppressive agentsmay 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 organsillness such as heart, liver or kidney
Those who with other autoimmune diseases or primary immunodeficiencies or tumors
Those who have participated in other clinical trials within three months prior tothe enrollment
Those who was not suitable for participating this study judged by investigator
Study Design
Study Description
Connect with a study center
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting

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