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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

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.

Condition or disease Intervention/treatment
IgA Nephropathy Proteinuria in Nephrotic Range Immunosuppressive Treatment Drug: Corticosteroid Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Dipyridamole Drug: ACE Inhibitor or Angiotensin receptor antagonist

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Registry of IgA Nephropathy in Chinese Children
Study Start Date : January 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
corticosteroid
pediatric IgA nephropathy treated with only corticosteroid
Drug: Corticosteroid
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone
  • Deflazacort

Drug: Dipyridamole
Drug: ACE Inhibitor or Angiotensin receptor antagonist
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
Drug: Corticosteroid
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone
  • Deflazacort

Drug: Cyclophosphamide
Other Name: CTX

Drug: Dipyridamole
Drug: ACE Inhibitor or Angiotensin receptor antagonist
corticosteroid and mycophenolate mofetil
pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
Drug: Corticosteroid
Other Names:
  • Steroid
  • Prednisone
  • Methylprednisone
  • Prednisolone
  • Deflazacort

Drug: Mycophenolate mofetil
Other Name: MMF

Drug: Dipyridamole
Drug: ACE Inhibitor or Angiotensin receptor antagonist



Primary Outcome Measures :
  1. 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.

  2. Renal dysfunction [ Time Frame: Two years ]
    Renal dysfunction is defined as eGFR declined by more than 50%.

  3. Hypertension [ Time Frame: Two years ]
    Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.


Secondary Outcome Measures :
  1. 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.

  2. Mortality [ Time Frame: Two years ]
    Death of participants will be recorded.


Biospecimen Retention:   Samples With DNA
The urine, serum and DNA of participants are expected to be collected and preserved.


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:   1 Month 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 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide.
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.

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): NCT03015974


Contacts
Layout table for location contacts
Contact: Xuhui Zhong, Dr. 8613683556856 xuhui7876@126.com
Contact: Jie Ding, Prof. 861083573238 djnc_5855@126.com

Locations
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China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Xuhui Zhong, Dr.    8613683556856    xuhui7876@126.com   
Sponsors and Collaborators
Peking University First Hospital
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
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Principal Investigator: Jie Ding, Prof. Peking University First Hospital
Additional Information:

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Responsible Party: Jie Ding, Prof., Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03015974    
Other Study ID Numbers: 2015[992]
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Proteinuria
Glomerulonephritis, IGA
Urologic Diseases
Urination Disorders
Urological Manifestations
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisone
Prednisolone
Deflazacort
Cyclophosphamide
Dipyridamole
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones