Registry of IgA Nephropathy in Chinese Children (RACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03015974

Recruitment Status : Recruiting

First Posted : January 10, 2017

Last Update Posted : September 16, 2020

See Contacts and Locations

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

Study Description

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.

Establishment of registration database online.
Participants will be enrolled according to the inclusion criteria and exclusion criteria.
The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
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 Design

Layout table for study information

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

Genetic and Rare Diseases Information Center resources: IgA Nephropathy Glomerulonephritis

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Biospecimen Retention: Samples With DNA

The urine, serum and DNA of participants are expected to be collected and preserved.

Eligibility Criteria

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.

Layout table for eligibility information

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.

Contacts and Locations

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

Layout table for location information

China
Peking University First Hospital	Recruiting
Beijing, China, 100034
Contact: Xuhui Zhong, Dr. 8613683556856 xuhui7876@126.com

Sponsors and Collaborators

Peking University First Hospital