IgA NephropathyRACCNCT03015974
Registry of IgA Nephropathy in Chinese Children
An observational study of IgA Nephropathy and Proteinuria in Nephrotic Range, run by Peking University First Hospital at 1 site in China.
Trial summary
This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- IgA Nephropathy, Proteinuria in Nephrotic Range, Immunosuppressive Treatment
- What is being tested?
- Corticosteroid, Cyclophosphamide and Mycophenolate mofetil
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2024
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide.
Who may be able to join
- Clinical diagnosis of primary IgA nephropathy.
- Presenting with nephrotic proteinuria, defined as 24-hour urinary protein>50mg/kg, or UPC>2.0 mg/mg.
- Informed consent must be signed.
Who cannot join
- Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Xuhui Zhong, Dr., 8613683556856, xuhui7876@126.com
About this study
This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.
Read the detailed description
A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.
- Establishment of registration database online.
- Participants will be enrolled according to the inclusion criteria and exclusion criteria.
- The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
- SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.
- Being tested
- Corticosteroid, Cyclophosphamide, Mycophenolate mofetil, Dipyridamole, ACE Inhibitor or Angiotensin receptor antagonist
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Steroid, Prednisone, Methylprednisone, Prednisolone
CyclophosphamideDrug
Also called CTX
Also called MMF
DipyridamoleDrug
ACE Inhibitor or Angiotensin receptor antagonistDrug
| Study group | Role | What they receive |
|---|---|---|
| corticosteroid | pediatric IgA nephropathy treated with only corticosteroid Receives: Drug: Corticosteroid; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonist | |
| corticosteroid and cyclophosphamide | pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide Receives: Drug: Corticosteroid; Drug: Cyclophosphamide; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonist | |
| corticosteroid and mycophenolate mofetil | pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil Receives: Drug: Corticosteroid; Drug: Mycophenolate mofetil; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of proteinuria
Complete remission is defined as 24-hour urine protein<150mg or UPC<0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function.
Measured: Two years
Renal dysfunction
Renal dysfunction is defined as eGFR declined by more than 50%.
Measured: Two years
Hypertension
Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.
Measured: Two years
Secondary outcomes (2)
End stage renal disease(ESRD)
ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.
Measured: Two years
Mortality
Death of participants will be recorded.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing PLA General Hospital, Beijing Children's Hospital, Central South University, The Children's Hospital of Zhejiang University School of Medicine, First Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Hunan Children's Hospital, Shanghai Children's Hospital, Nanjing Children's Hospital, Children's Hospital of Chongqing Medical University, Shandong Provincial Hospital, Fuzhou General Hospital, Second Affiliated Hospital of Wenzhou Medical University, Children's Hospital of Hebei Province, Guangzhou Women and Children's Medical Center, Jiangxi Province Children's Hospital, Guangzhou First People's Hospital, Xian Children's Hospital, Capital Institute of Pediatrics, China, The First Hospital of Jilin University, Wuhan Women and Children's Medical Center, Tianjin Children's Hospital, Chengdu Women's and Children's Central Hospital, The First People's Hospital of Yunnan
- Responsible party
- Principal investigator, Jie Ding, Peking University First Hospital
- Investigators
- Jie Ding, Prof., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015974
- Sponsor's protocol ID
- 2015[992]
- Acronym
- RACC
- Status last verified
- Dec 2023
- First submitted
- 3 Jan 2017
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of IgA Nephropathy in Chinese Children
- ClinicalTrials.gov ID
- NCT03015974
- Acronym / sponsor ID
- RACC / 2015[992]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Nanjing PLA General Hospital, Beijing Children's Hospital, Central South University, The Children's Hospital of Zhejiang University School of Medicine, First Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Hunan Children's Hospital, Shanghai Children's Hospital, Nanjing Children's Hospital, Children's Hospital of Chongqing Medical University, Shandong Provincial Hospital, Fuzhou General Hospital, Second Affiliated Hospital of Wenzhou Medical University, Children's Hospital of Hebei Province, Guangzhou Women and Children's Medical Center, Jiangxi Province Children's Hospital, Guangzhou First People's Hospital, Xian Children's Hospital, Capital Institute of Pediatrics, China, The First Hospital of Jilin University, Wuhan Women and Children's Medical Center, Tianjin Children's Hospital, Chengdu Women's and Children's Central Hospital, The First People's Hospital of Yunnan
- Study start
- Jan 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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.
This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.
Detailed description
A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.
- Establishment of registration database online.
- Participants will be enrolled according to the inclusion criteria and exclusion criteria.
- The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
- SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| corticosteroid | – | Drug: Corticosteroid, Drug: Dipyridamole, Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with only corticosteroid |
| corticosteroid and cyclophosphamide | – | Drug: Corticosteroid, Drug: Cyclophosphamide, Drug: Dipyridamole, Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with corticosteroid and cyclophosphamide |
| corticosteroid and mycophenolate mofetil | – | Drug: Corticosteroid, Drug: Mycophenolate mofetil, Drug: Dipyridamole, Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide.
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary IgA nephropathy.
- Presenting with nephrotic proteinuria, defined as 24-hour urinary protein>50mg/kg, or UPC>2.0 mg/mg.
- Informed consent must be signed.
Key exclusion criteria (1 listed)
- Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
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 |
|---|---|---|
| CorticosteroidAlso: Steroid, Prednisone, Methylprednisone, Prednisolone | Drug | corticosteroid, corticosteroid and cyclophosphamide, corticosteroid and mycophenolate mofetil |
| CyclophosphamideAlso: CTX | Drug | corticosteroid and cyclophosphamide |
| Mycophenolate mofetilAlso: MMF | Drug | corticosteroid and mycophenolate mofetil |
| Dipyridamole | Drug | corticosteroid, corticosteroid and cyclophosphamide, corticosteroid and mycophenolate mofetil |
| ACE Inhibitor or Angiotensin receptor antagonist | Drug | corticosteroid, corticosteroid and cyclophosphamide, corticosteroid and mycophenolate mofetil |
Primary outcome
Improvement of proteinuria
Time frame: Two years
Complete remission is defined as 24-hour urine protein<150mg or UPC<0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function.
Renal dysfunction
Time frame: Two years
Renal dysfunction is defined as eGFR declined by more than 50%.
Hypertension
Time frame: Two years
Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.
2 secondary outcomes
End stage renal disease(ESRD)
Time frame: Two years
Mortality
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jie Ding, Prof. principal investigator
Peking University First 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 IgA Nephropathy and Proteinuria in Nephrotic Range, run by Peking University First 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 1 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhui Zhong, Dr. (8613683556856, xuhui7876@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of proteinuria (time frame: Two years). The study lists 3 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 6 Dec 2023.