Multicenter Registry of Pediatric Lupus Nephritis in China

April 3, 2019 updated by: Xiqiang Dang
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital, Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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:
  • Prednisolone
  • Prednisone
  • Steroid
  • Methylprednisone
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 Names:
  • anti-CD20 antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Death of patients
1 year, 2 years, 3 years, 4 years and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiqiang Dang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Anhui Medical University
LanZhou University
Guangzhou First People's Hospital
Shandong Provincial Hospital
Shanghai Children's Medical Center
Guizhou Provincial People's Hospital
Beijing Children's Hospital
The Second Hospital of Shandong University
The Second Affiliated Hospital of Harbin Medical University
Fujian Provincial Hospital
Yichang Central People's Hospital
Shenzhen Children's Hospital
The First Affiliated Hospital of Xiamen University
Second Hospital of Lanzhou University
First Affiliated Hospital of Guangxi Medical University
The Children's Hospital Affiliated to Suzhou University
The First Affiliated Hospital of Inner Mongolia Medical College
People's Hospital of Zhangjiajie
Puyang Oilfield General Hospital
Guizhou Maternal and Child Health Care Hospital
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University
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 Xinxiang Medical College
Shanxi Provincial Maternity and Children's Hospital
Liaocheng People's Hospital
Children's Hospital of Hebei Province
Zhengzhou Children's Hospital
The Children's Hospital of Chongqing Medical University
Wuxi Children's Hospital
The Children's Hospital of Fudan University
Qilu Children's Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pediatric lupus nephritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Currently, IPD is not available to other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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