Status:
COMPLETED
Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome
Lead Sponsor:
The Children's Hospital of Zhejiang University School of Medicine
Collaborating Sponsors:
Children's Hospital of Fudan University
Peking University First Hospital
Conditions:
Nephrotic Syndrome in Children
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief 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 stero...
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04048161
Start Date
November 12 2019
End Date
July 12 2023
Last Update
October 17 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100032
2
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 401122
3
First Affiliated Hospital of Zhongshan Medical University
Guangzhou, Guangdong, China, 510080
4
Henan Children's Hospital
Zhengzhou, Henan, China, 451161