Registry of IgA Nephropathy in Chinese Children (RACC)

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.

Study Overview

• Status: Recruiting
• Conditions: IgA Nephropathy; Immunosuppressive Treatment; Proteinuria in Nephrotic Range
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Mycophenolate mofetil; Drug: Dipyridamole; Drug: Corticosteroid; 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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Xuhui Zhong, Dr.; Phone Number: 8613683556856; Email: xuhui7876@126.com
• Study Contact Backup: Name: Jie Ding, Prof.; Phone Number: 861083573238; Email: djnc_5855@126.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
corticosteroid; pediatric IgA nephropathy treated with only corticosteroid	Drug: Dipyridamole; Drug: Corticosteroid; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Deflazacort; Drug: ACE Inhibitor or Angiotensin receptor antagonist
corticosteroid and cyclophosphamide; pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide	Drug: Cyclophosphamide; Other Names: CTX; Drug: Dipyridamole; Drug: Corticosteroid; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Deflazacort; Drug: ACE Inhibitor or Angiotensin receptor antagonist
corticosteroid and mycophenolate mofetil; pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil	Drug: Mycophenolate mofetil; Other Names: MMF; Drug: Dipyridamole; Drug: Corticosteroid; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Deflazacort; Drug: ACE Inhibitor or Angiotensin receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Renal dysfunction	Renal dysfunction is defined as eGFR declined by more than 50%.	Two years
Hypertension	Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End stage renal disease(ESRD)	ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.	Two years
Mortality	Death of participants will be recorded.	Two years

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Tongji Hospital; Guangzhou First People's Hospital; Shandong Provincial Hospital; Shanghai Children's Hospital; The First Hospital of Jilin University; Second Affiliated Hospital of Wenzhou Medical University; Central South University; Beijing Children's Hospital; Chengdu Women's and Children's Central Hospital; Fuzhou General Hospital; Hunan Children's Hospital; Guangzhou Women and Children's Medical Center; The Children's Hospital of Zhejiang University School of Medicine; Jiangxi Province Children's Hospital; Nanjing Children's Hospital; Children's Hospital of Chongqing Medical University; Nanjing PLA General Hospital; Xian Children's Hospital; The First People's Hospital of Yunnan; Children's Hospital of Hebei Province; Wuhan Women and Children's Medical Center; Tianjin Children's Hospital; Capital Institute of Pediatrics, China
• Investigators: Principal Investigator: Jie Ding, Prof., Peking University First Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimated): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Proteinuria; Glomerulonephritis, IGA; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Phosphodiesterase Inhibitors; Antibiotics, Antitubercular; Prednisolone; Cyclophosphamide; Prednisone; Dipyridamole; Mycophenolic Acid; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Deflazacort
• Other Study ID Numbers: 2015[992]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED