Registry of IgA Nephropathy in Chinese Children

IgA Nephropathy Clinical Trial

— RACC  

Official title:

Registry of IgA Nephropathy in Chinese Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03015974
• Other study ID #: 2015[992]
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Peking University First Hospital
• Contact: Xuhui Zhong, Dr.
• Phone: 8613683556856
• Email: xuhui7876[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Immunosuppressive Treatment
• Kidney Diseases
• Proteinuria
• Proteinuria in Nephrotic Range

Intervention

Drug:
• Corticosteroid

• Cyclophosphamide

• Mycophenolate mofetil

• Dipyridamole

• ACE Inhibitor or Angiotensin receptor antagonist

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing

Sponsors (25)

Lead Sponsor

Collaborator

Peking University First Hospital

Beijing Children's Hospital, Capital Institute of Pediatrics, China, Central South University, Chengdu Women's and Children's Central Hospital, Children's Hospital of Chongqing Medical University, Children's Hospital of Hebei Province, First Affiliated Hospital, Sun Yat-Sen University, Fuzhou General Hospital, Guangzhou First People's Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Province Children's Hospital, Nanjing Children's Hospital, Nanjing PLA General Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Hospital, Shanghai Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, The First Hospital of Jilin University, The First People's Hospital of Yunnan, Tianjin Children's Hospital, Tongji Hospital, Wuhan Women and Children's Medical Center, Xian Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of proteinuria	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.	Two years
Primary	Renal dysfunction	Renal dysfunction is defined as eGFR declined by more than 50%.	Two years
Primary	Hypertension	Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.	Two years
Secondary	End stage renal disease(ESRD)	ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.	Two years
Secondary	Mortality	Death of participants will be recorded.	Two years