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Multicenter Registry of Pediatric Lupus Nephritis in China

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ClinicalTrials.gov Identifier: NCT03791827
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : April 5, 2019
Sponsor:
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 Oil Field General Hospital
The First Affiliated Hospital of Anhui Medical University
Guizhou Maternal and Child Health Care Hospital
The Second Affiliated Hospital & Yuying Children's 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
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & 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 City People's Hospital
Fujian Provincial Hospital
First Affiliated Hospital of Guangxi Medical University
Second Hospital of Lanzhou University
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
The Children's Hospital of Chongqing Medical University
Wuxi Children's Hospital
The Children's Hospital of Fudan University
Shanghai Children's Medical Center
Qilu Children's Hospital of Shandong University
Information provided by (Responsible Party):
Xiqiang Dang, Second Xiangya Hospital of Central South University

Brief 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.

Condition or disease Intervention/treatment
Lupus Nephritis Children Steroid Immunosuppressive Treatment Drug: Corticosteroid Drug: Hydroxychloroquine Drug: Cyclophosphamide Drug: Mycophenolate Mofetil Drug: Azathioprine Drug: Tacrolimus Drug: Cyclosporine A Drug: Rituximab

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Registry of Pediatric Lupus Nephritis in China
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Corticosteroid
Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Corticosteroid and cyclophosphamide
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Cyclophosphamide
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.

Corticosteroid and mycophenolate mofetil
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Mycophenolate Mofetil
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d

Corticosteroid and azathioprine
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d

Corticosteroid and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Tacrolimus
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h

Corticosteroid and cyclosporine A
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h

Corticosteroid, mycophenolate mofetil and tacrolimus
Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Drug: Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone

Drug: Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Drug: Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d

Drug: Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h

Retuximab
An option for refractory lupus nephritis
Drug: Rituximab
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
Other Name: anti-CD20 antibody




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. End stage renal disease (ESRD) [ Time Frame: 1 year, 2 years, 3 years, 4 years and 5 years ]
    ESRD is defined as eGFR<15ml/1.73m2, initiation of long-term dialysis or kidney

  2. Mortality [ Time Frame: 1 year, 2 years, 3 years, 4 years and 5 years ]
    Death of patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria (either of the following criteria):

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791827


Contacts
Layout table for location contacts
Contact: Xiqiang Dang, M.D. 8613739052618 dangxiqiang@csu.edu.cn
Contact: Tian Shen, M.D 8613548764640 shentian0215@csu.edu.cn

Locations
Layout table for location information
China, Hunan
The Second Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Tian Shen, M.D.    +8613548764640    shentian0215@csu.edu.cn   
Sponsors and Collaborators
Xiqiang Dang
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 Oil Field General Hospital
The First Affiliated Hospital of Anhui Medical University
Guizhou Maternal and Child Health Care Hospital
The Second Affiliated Hospital & Yuying Children's 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
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & 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 City People's Hospital
Fujian Provincial Hospital
First Affiliated Hospital of Guangxi Medical University
Second Hospital of Lanzhou University
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
The Children's Hospital of Chongqing Medical University
Wuxi Children's Hospital
The Children's Hospital of Fudan University
Shanghai Children's Medical Center
Qilu Children's Hospital of Shandong University

Layout table for additonal information
Responsible Party: Xiqiang Dang, Professor, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03791827     History of Changes
Other Study ID Numbers: Pediatric lupus nephritis
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, IPD is not available to other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Tacrolimus
Cyclosporins
Cyclosporine
Azathioprine
Rituximab
Hydroxychloroquine
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Calcineurin Inhibitors
Enzyme Inhibitors
Antifungal Agents