An observational study in Nephrotic Syndrome, Adolescent and Biopsy, sponsored by Nanjing Children's Hospital. Active, not recruiting at 1 site in China. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Nanjing Children's Hospital · Observational
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.
Pediatric kidney disease, especially primary nephrotic syndrome (PNS), is a common urinary system disease in pediatric clinical practice. The core pathophysiological process of nephrotic syndrome involves damage to the glomerular filtration membrane, resulting in massive proteinuria and subsequent hypoproteinemia, hyperlipidemia, and edema. PNS in children is more prevalent in the preschool age group, with minimal change disease (MCD) accounting for approximately 77.1% of pathological types. MCD is sensitive to corticosteroids, and the traditional initial treatment regimen is standard-dose corticosteroid induction therapy. In foreign countries, the pathological types of PNS in adolescents are mainly MCD and focal segmental glomerulosclerosis (FSGS). In mainland China, the proportion of mesangial proliferative glomerulonephritis (MsPGN) is increasing, but MCD remains the main pathological type. Currently, there is no consensus among guidelines from various countries on whether to perform renal biopsy and the indications for it in adolescent PNS. The Chinese pediatric PNS evidence-based guideline does not specify the age factor for renal biopsy. In the treatment protocol debate of the International Pediatric Nephrology Association (IPNA), some scholars advocate corticosteroid treatment first, while others believe that renal biopsy first can reduce steroid exposure and its side effects. However, there is still a lack of large-scale clinical data for comparison. 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.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 400 is above the median of 125 across 59 observational studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinical data of PNS patients aged 10-18 years who met the diagnostic criteria for pediatric PNS established by the Pediatric Nephrology Group of the Chinese Medical Association in 2016, from multiple medical institutions over the past decade.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At the initial diagnosis, treatment is initiated with corticosteroids or immunosuppressive agents.
At the initial diagnosis, renal biopsy is performed first to clarify the renal pathology, and then targeted medication is used.
Procedure: Renal Biopsy
Renal biopsy is performed to clarify the renal pathology.
The number of relapses of proteinuria
The total number of proteinuria relapses in patients within 2 years of treatment is counted.
Time frame: From the start of treatment to 1 year and 2 years.
A 50% decline in kidney function
Calculate the proportion of patients with a greater than 50% decline in kidney function at 6 months, 1 year, and 2 years of treatment.
Time frame: At 6 months, 1 year, and 2 years of treatment.
Relapse-free rate of proteinuria after treatment
The proportion of participants who remain free of proteinuria relapse after initial treatment, assessed by urine analysis and clinical evaluation.
Time frame: At 3 months, 6 months, 1 year, and 2 years after treatment initiation.
Incidence of steroid resistance after treatment
The proportion of participants who do not achieve remission with standard steroid therapy, assessed clinically and by laboratory evaluation.
Time frame: At 4 weeks after treatment initiation.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Nanjing Children's Hospital