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Registry of IgA Nephropathy in Chinese Children (RACC)

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ClinicalTrials.gov Identifier: NCT03015974
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : September 16, 2020
Sponsor:
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
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
Information provided by (Responsible Party):
Jie Ding, Peking University First Hospital

Tracking Information
First Submitted Date January 3, 2017
First Posted Date January 10, 2017
Last Update Posted Date September 16, 2020
Study Start Date January 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 6, 2017)
  • End stage renal disease(ESRD) [ Time Frame: Two years ]
    ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.
  • Mortality [ Time Frame: Two years ]
    Death of participants will be recorded.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of IgA Nephropathy in Chinese Children
Official Title Registry of IgA Nephropathy in Chinese Children
Brief 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.
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.

  1. Establishment of registration database online.
  2. Participants will be enrolled according to the inclusion criteria and exclusion criteria.
  3. The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
  4. 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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Retention:   Samples With DNA
Description:
The urine, serum and DNA of participants are expected to be collected and preserved.
Sampling Method Non-Probability Sample
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.
Condition
  • IgA Nephropathy
  • Proteinuria in Nephrotic Range
  • Immunosuppressive Treatment
Intervention
  • Drug: Corticosteroid
    Other Names:
    • Steroid
    • Prednisone
    • Methylprednisone
    • Prednisolone
    • Deflazacort
  • Drug: Cyclophosphamide
    Other Name: CTX
  • Drug: Mycophenolate mofetil
    Other Name: MMF
  • Drug: Dipyridamole
  • Drug: ACE Inhibitor or Angiotensin receptor antagonist
Study Groups/Cohorts
  • corticosteroid
    pediatric IgA nephropathy treated with only corticosteroid
    Interventions:
    • Drug: Corticosteroid
    • Drug: Dipyridamole
    • Drug: ACE Inhibitor or Angiotensin receptor antagonist
  • corticosteroid and cyclophosphamide
    pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
    Interventions:
    • 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
    Interventions:
    • Drug: Corticosteroid
    • Drug: Mycophenolate mofetil
    • Drug: Dipyridamole
    • Drug: ACE Inhibitor or Angiotensin receptor antagonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 6, 2017)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

In-patients will be enrolled with the following criteria.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xuhui Zhong, Dr. 8613683556856 xuhui7876@126.com
Contact: Jie Ding, Prof. 861083573238 djnc_5855@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03015974
Other Study ID Numbers 2015[992]
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jie Ding, Peking University First Hospital
Study Sponsor Peking University First Hospital
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
  • 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
Investigators
Principal Investigator: Jie Ding, Prof. Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date September 2020