Nephrotic SyndromeNCT07071597
The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome.
An observational study of Nephrotic Syndrome and Adolescent, run by Nanjing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Nephrotic Syndrome, Adolescent, Biopsy
- What is being tested?
- Renal Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome: A Multicenter Real-World Study.
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.
Read the 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
- Being tested
- Renal Biopsy
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal BiopsyProcedure or surgery
Renal biopsy is performed to clarify the renal pathology.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Renal Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of relapses of proteinuria
The total number of proteinuria relapses in patients within 2 years of treatment is counted.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 4 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yajing Xun, Nanjing Children's Hospital
- Investigators
- Ruochen Che, Principal investigator, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071597
- Sponsor's protocol ID
- 202412043-1
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Selection of Initial Treatment Regimens for Adolescent Nephrotic Syndrome: A Multicenter Real-World Study.
- ClinicalTrials.gov ID
- NCT07071597
- Acronym / sponsor ID
- 202412043-1
- Conditions
- Nephrotic Syndrome, Adolescent, Biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | –At the initial diagnosis, treatment is initiated with corticosteroids or immunosuppressive agents. |
| Renal Biopsy Group | – | Procedure: Renal BiopsyAt the initial diagnosis, renal biopsy is performed first to clarify the renal pathology, and then targeted medication is used. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal BiopsyRenal biopsy is performed to clarify the renal pathology. | Procedure or surgery | Renal Biopsy Group |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruochen Che principal investigator
Nanjing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome and Adolescent, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of relapses of proteinuria (time frame: From the start of treatment to 1 year and 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.