Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Children's Hospital Affiliated to Suzhou University | UNKNOWN |
| Shandong Provincial Hospital | OTHER_GOV |
| Guizhou Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid | Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid |
| |
| Corticosteroid and cyclophosphamide | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide |
| |
| Corticosteroid and mycophenolate mofetil | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil |
| |
| Corticosteroid and azathioprine | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine |
| |
| Corticosteroid and tacrolimus | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | corticosteroid is given to patients orally or methylprednisone is given to patients through i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| End stage renal disease (ESRD) | ESRD is defined as eGFR<15ml/1.73m2, initiation of long-term dialysis or kidney | 1 year, 2 years, 3 years, 4 years and 5 years |
| Mortality | Death of patients |
Not provided
Inclusion Criteria:
Diagnosis of lupus nephritis:
Exclusion Criteria (either of the following criteria):
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiqiang Dang, M.D. | Contact | 8613739052618 | dangxiqiang@csu.edu.cn | |
| Tian Shen, M.D | Contact | 8613548764640 | shentian0215@csu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410011 | China |
Currently, IPD is not available to other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D013256 | Steroids |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| D006886 | Hydroxychloroquine |
| D003520 | Cyclophosphamide |
| D009173 | Mycophenolic Acid |
| D001379 | Azathioprine |
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| LanZhou University |
| OTHER |
| The First Affiliated Hospital of Inner Mongolia Medical College | UNKNOWN |
| People's Hospital of Zhangjiajie | UNKNOWN |
| Puyang Oilfield General Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Guizhou Maternal and Child Health Care Hospital | UNKNOWN |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shenzhen Children's Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Yichang Central People's Hospital | OTHER |
| Xian Children's Hospital | OTHER_GOV |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| The First Affiliated Hospital of Xinxiang Medical College | OTHER |
| Shanxi Provincial Maternity and Children's Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Lanzhou University Second Hospital | OTHER |
| Guangzhou First People's Hospital | OTHER |
| The Second Hospital of Shandong University | OTHER |
| Children's Hospital of Hebei Province | OTHER |
| Beijing Children's Hospital | OTHER |
| Zhengzhou Children's Hospital | UNKNOWN |
| Children's Hospital of Chongqing Medical University | OTHER |
| Wuxi Women's & Children's Hospital | OTHER |
| The Children's Hospital of Fudan University | UNKNOWN |
| Shanghai Children's Medical Center | OTHER |
| Qilu Children's Hospital of Shandong University | OTHER |
Not provided
Not provided
Not provided
| Corticosteroid and cyclosporine A | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A |
|
| Corticosteroid, mycophenolate mofetil and tacrolimus | Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus |
|
| Retuximab | An option for refractory lupus nephritis |
|
|
| Hydroxychloroquine | Drug | Hydroxychloroquine is recommended as the basic therapy for lupus nephritis |
|
| Cyclophosphamide | Drug | 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. |
|
| Mycophenolate Mofetil | Drug | The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d |
|
| Azathioprine | Drug | The recommended dose of azathioprine is 1.5 to 2mg/kg/d |
|
| Tacrolimus | Drug | The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h |
|
| Cyclosporine A | Drug | The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h |
|
| Rituximab | Drug | The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses |
|
|
| 1 year, 2 years, 3 years, 4 years and 5 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D018942 | Macrolides |
| D007783 | Lactones |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |