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Active, Not Recruiting

NCT Number: NCT07071597

The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NanjingCH

Nanjing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Incomplete clinical data.

Treatment and study plan

Renal Biopsy

Procedure

Renal biopsy is performed to clarify the renal pathology.

Primary outcomes

  1. The number of relapses of proteinuria

    Time frame: From the start of treatment to 1 year and 2 years.

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

  2. A 50% decline in kidney function

    Time frame: At 6 months, 1 year, and 2 years of treatment.

    Calculate the proportion of patients with a greater than 50% decline in kidney function at 6 months, 1 year, and 2 years of treatment.

  3. Relapse-free rate of proteinuria after treatment

    Time frame: At 3 months, 6 months, 1 year, and 2 years after treatment initiation.

    The proportion of participants who remain free of proteinuria relapse after initial treatment, assessed by urine analysis and clinical evaluation.

  4. Incidence of steroid resistance after treatment

    Time frame: At 4 weeks after treatment initiation.

    The proportion of participants who do not achieve remission with standard steroid therapy, assessed clinically and by laboratory evaluation.

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome: A Multicenter Real-World Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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