The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome.

NCT07071597 | Active Not Recruiting DMC

• 1 other identifier: 202412043-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome; Adolescent; Biopsy

Outcome Measures

Primary Outcomes (4)

• The number of relapses of proteinuria

  The total number of proteinuria relapses in patients within 2 years of treatment is counted.

  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.

  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.

  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.

  At 4 weeks after treatment initiation.

Study Arms (2)

Treatment Group

At the initial diagnosis, treatment is initiated with corticosteroids or immunosuppressive agents.

Renal Biopsy Group

At the initial diagnosis, renal biopsy is performed first to clarify the renal pathology, and then targeted medication is used.

Procedure: Renal Biopsy

Interventions

Renal Biopsy PROCEDURE

Renal biopsy is performed to clarify the renal pathology.

Renal Biopsy Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Incomplete clinical data.

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

NanjingCH

Nanjing, China

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ruochen Che

  Nanjing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)