The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome.

NCT ID: NCT07071597

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

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.

Conditions

Nephrotic Syndrome; Adolescent; Biopsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Treatment Group

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

No interventions assigned to this group

Renal Biopsy Group

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

Renal Biopsy

Intervention Type: PROCEDURE

Renal biopsy is performed to clarify the renal pathology.

Interventions

Renal Biopsy

Renal biopsy is performed to clarify the renal pathology.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.);

2. Regular follow-up for at least 1 year;

3. Compliance with the requirements of the revised Helsinki Declaration of 2013, with informed consent obtained from patients and their families.

Exclusion Criteria

1. Nephrotic syndrome secondary to other diseases;

2. Patients requiring dialysis or after kidney transplantation;

3. Presence of genetic defects or hereditary metabolic diseases;

4. Concurrent with severe primary diseases such as cardiovascular, liver, brain, hematopoietic system diseases, or mental disorders;

5. Incomplete clinical data.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yajing Xun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruochen Che

Role: PRINCIPAL_INVESTIGATOR

Nanjing Children's Hospital

Locations

NanjingCH

Nanjing, , China

Countries

China

Other Identifiers

202412043-1

Identifier Type: -

Identifier Source: org_study_id