Lupus NephritisNCT03791827
Multicenter Registry of Pediatric Lupus Nephritis in China
An observational study of Lupus Nephritis and Children, run by Xiqiang Dang at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Lupus Nephritis, Children, Steroid
- What is being tested?
- Corticosteroid, Hydroxychloroquine and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Nov 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 1200 pediatric lupus nephritis patients younger than 18 years old will be enrolled from more than 35 pediatric nephrology medical centers nationwide
Who may be able to join
- Diagnosis of lupus nephritis:
- Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
- Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein>150mg, or UPC>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis
- The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003
Who cannot join
- Complicated with other systemic diseases, including basic diseases with clinical significance
- Patients with tumors
- Patients with abnormal glucose metabolism
- Immunodeficiency patients
- Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment
- Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.)
- Drug-induced lupus, congenital lupus and other secondary lupus
- Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Tian Shen, M.D., +8613548764640, shentian0215@csu.edu.cn
About this study
This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.
- Conditions
- Lupus Nephritis, Children, Steroid, Immunosuppressive Treatment
- Being tested
- Corticosteroid, Hydroxychloroquine, Cyclophosphamide, Mycophenolate Mofetil, Azathioprine
- Medical subject headings
- Lupus Nephritis
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
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
CyclophosphamideDrug
The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
AzathioprineDrug
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
TacrolimusDrug
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
Cyclosporine ADrug
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
RituximabDrug
Also called anti-CD20 antibody
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine | |
| Corticosteroid and cyclophosphamide | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Cyclophosphamide | |
| Corticosteroid and mycophenolate mofetil | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Mycophenolate Mofetil | |
| Corticosteroid and azathioprine | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Azathioprine | |
| Corticosteroid and tacrolimus | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Tacrolimus | |
| Corticosteroid and cyclosporine A | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Cyclosporine A | |
| Corticosteroid, mycophenolate mofetil and tacrolimus | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus Receives: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Azathioprine; Drug: Cyclosporine A | |
| Retuximab | An option for refractory lupus nephritis Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
complete remission is defined as UPC<0.2 mg/mg， or 24-hour urine protein<150mg with normal kidney function and without hematuria
Measured: 5 years
Partial remission
Partial remission is defined as non-nephrotic range proteinura, decrease of urine protein ≥50%， and serum creatinine remains stable (±25% of baseline) or is improved but not normal yet
Measured: 5 years
Secondary outcomes (2)
End stage renal disease (ESRD)
ESRD is defined as eGFR<15ml/1.73m2, initiation of long-term dialysis or kidney
Measured: 1 year, 2 years, 3 years, 4 years and 5 years
Mortality
Death of patients
Measured: 1 year, 2 years, 3 years, 4 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Dec 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiqiang Dang
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital Affiliated to Suzhou University, Shandong Provincial Hospital, Guizhou Provincial People's Hospital, LanZhou University, The First Affiliated Hospital of Inner Mongolia Medical College, People's Hospital of Zhangjiajie, Puyang Oilfield General Hospital, The First Affiliated Hospital of Anhui Medical University, Guizhou Maternal and Child Health Care Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shenzhen Children's Hospital, The Second Affiliated Hospital of Harbin Medical University, Yichang Central People's Hospital, Xian Children's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First People's Hospital of Yunnan, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Xinxiang Medical College, Shanxi Provincial Maternity and Children's Hospital, Liaocheng People's Hospital, Fujian Provincial Hospital, First Affiliated Hospital of Guangxi Medical University, Lanzhou University Second Hospital, Guangzhou First People's Hospital, The Second Hospital of Shandong University, Children's Hospital of Hebei Province, Beijing Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital of Chongqing Medical University, Wuxi Women's & Children's Hospital, Children's Hospital of Fudan University, Shanghai Children's Medical Center, Qilu Children's Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Xiqiang Dang, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791827
- Sponsor's protocol ID
- Pediatric lupus nephritis
- Status last verified
- Apr 2019
- First submitted
- 24 Dec 2018
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, IPD is not available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry of Pediatric Lupus Nephritis in China
- ClinicalTrials.gov ID
- NCT03791827
- Acronym / sponsor ID
- Pediatric lupus nephritis
- Conditions
- Lupus Nephritis, Children, Steroid, Immunosuppressive Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Xiqiang DangUniversity, hospital or other
- Collaborators
- The Children's Hospital Affiliated to Suzhou University, Shandong Provincial Hospital, Guizhou Provincial People's Hospital, LanZhou University, The First Affiliated Hospital of Inner Mongolia Medical College, People's Hospital of Zhangjiajie, Puyang Oilfield General Hospital, The First Affiliated Hospital of Anhui Medical University, Guizhou Maternal and Child Health Care Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shenzhen Children's Hospital, The Second Affiliated Hospital of Harbin Medical University, Yichang Central People's Hospital, Xian Children's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First People's Hospital of Yunnan, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Xinxiang Medical College, Shanxi Provincial Maternity and Children's Hospital, Liaocheng People's Hospital, Fujian Provincial Hospital, First Affiliated Hospital of Guangxi Medical University, Lanzhou University Second Hospital, Guangzhou First People's Hospital, The Second Hospital of Shandong University, Children's Hospital of Hebei Province, Beijing Children's Hospital, Zhengzhou Children's Hospital, Children's Hospital of Chongqing Medical University, Wuxi Women's & Children's Hospital, Children's Hospital of Fudan University, Shanghai Children's Medical Center, Qilu Children's Hospital of Shandong University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 3 Jan 2019 (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.
This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | – | Drug: Corticosteroid, Drug: HydroxychloroquinePediatric lupus nephritis treated with hydroxychloroquine and corticosteroid |
| Corticosteroid and cyclophosphamide | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: CyclophosphamidePediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide |
| Corticosteroid and mycophenolate mofetil | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: Mycophenolate MofetilPediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil |
| Corticosteroid and azathioprine | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: AzathioprinePediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine |
| Corticosteroid and tacrolimus | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: TacrolimusPediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus |
| Corticosteroid and cyclosporine A | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: Cyclosporine APediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A |
| Corticosteroid, mycophenolate mofetil and tacrolimus | – | Drug: Corticosteroid, Drug: Hydroxychloroquine, Drug: Azathioprine, Drug: Cyclosporine APediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus |
| Retuximab | – | Drug: RituximabAn option for refractory lupus nephritis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 1200 pediatric lupus nephritis patients younger than 18 years old will be enrolled from more than 35 pediatric nephrology medical centers nationwide
Key inclusion criteria (4 listed)
- Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
- Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein>150mg, or UPC>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis
- The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003
Key exclusion criteria (8 listed)
- Complicated with other systemic diseases, including basic diseases with clinical significance
- Patients with tumors
- Patients with abnormal glucose metabolism
- Immunodeficiency patients
- Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment
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, Prednisolonecorticosteroid is given to patients orally or methylprednisone is given to patients through i.v. | Drug | Corticosteroid, Corticosteroid and azathioprine, Corticosteroid and cyclophosphamide, Corticosteroid and cyclosporine A, Corticosteroid and mycophenolate mofetil, Corticosteroid and tacrolimus, Corticosteroid, mycophenolate mofetil and tacrolimus |
| HydroxychloroquineHydroxychloroquine is recommended as the basic therapy for lupus nephritis | Drug | Corticosteroid, Corticosteroid and azathioprine, Corticosteroid and cyclophosphamide, Corticosteroid and cyclosporine A, Corticosteroid and mycophenolate mofetil, Corticosteroid and tacrolimus, Corticosteroid, mycophenolate mofetil and tacrolimus |
| CyclophosphamideThe typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v. | Drug | Corticosteroid and cyclophosphamide |
| Mycophenolate MofetilThe recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d | Drug | Corticosteroid and mycophenolate mofetil |
| AzathioprineThe recommended dose of azathioprine is 1.5 to 2mg/kg/d | Drug | Corticosteroid and azathioprine, Corticosteroid, mycophenolate mofetil and tacrolimus |
| TacrolimusThe recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h | Drug | Corticosteroid and tacrolimus |
| Cyclosporine AThe recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h | Drug | Corticosteroid and cyclosporine A, Corticosteroid, mycophenolate mofetil and tacrolimus |
| RituximabAlso: anti-CD20 antibodyThe recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses | Drug | Retuximab |
Primary outcome
Complete remission
Time frame: 5 years
complete remission is defined as UPC<0.2 mg/mg， or 24-hour urine protein<150mg with normal kidney function and without hematuria
Partial remission
Time frame: 5 years
Partial remission is defined as non-nephrotic range proteinura, decrease of urine protein ≥50%， and serum creatinine remains stable (±25% of baseline) or is improved but not normal yet
2 secondary outcomes
End stage renal disease (ESRD)
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years
Mortality
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: No. Currently, IPD is not available to other researchers
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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.
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 Lupus Nephritis and Children, run by Xiqiang Dang 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 4 inclusion and 8 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 5 Apr 2019. 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 Xiqiang Dang, M.D. (8613739052618, dangxiqiang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: 5 years). The study lists 2 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 5 Apr 2019.