The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome. (NCT07071597) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome.
China400 participantsStarted 2025-06-01
Plain-language summary
Given that the treatment strategy for adolescent PNS has a significant impact on growth and development, but there are few cases and a lack of clinical research, this study plans to collaborate with several domestic top-tier children's nephrology centers to conduct a retrospective real-world study of adolescent PNS. The aim is to understand the current diagnosis and treatment status of adolescent PNS and compare the advantages and disadvantages of various therapies, in order to provide a more scientific, rational, and effective treatment plan for adolescent PNS.
Who can participate
Age range10 Years – 18 Years
SexALL
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Inclusion criteria
✓. Clinical diagnosis met the criteria for PNS from January 2014 to December 2023 (①Nephrotic-range proteinuria: 24-h urine protein ≥50 mg/kg or morning urine protein/creatinine (mg/mg) ≥2.0, three consecutive morning urine protein tests (＋＋＋) to (＋＋＋＋) within 1 week. ②Hypoproteinemia: serum albumin \<25 g/L. ③Hyperlipidemia: serum cholesterol \>5.7 mmol/L. ④Edema to varying degrees. Among the above four criteria, 1 and 2 are essential for diagnosis.);
✓. Regular follow-up for at least 1 year;
✓. Compliance with the requirements of the revised Helsinki Declaration of 2013, with informed consent obtained from patients and their families.
Exclusion criteria
✕. Nephrotic syndrome secondary to other diseases;
✕. Patients requiring dialysis or after kidney transplantation;
✕. Presence of genetic defects or hereditary metabolic diseases;
✕. Concurrent with severe primary diseases such as cardiovascular, liver, brain, hematopoietic system diseases, or mental disorders;
✕
What they're measuring
1
The number of relapses of proteinuria
Timeframe: From the start of treatment to 1 year and 2 years.
2
A 50% decline in kidney function
Timeframe: At 6 months, 1 year, and 2 years of treatment.
3
Relapse-free rate of proteinuria after treatment
Timeframe: At 3 months, 6 months, 1 year, and 2 years after treatment initiation.