Registry of IgA Nephropathy in Chinese Children

NCT03015974 | Unknown DMC

• 1 other identifier: 2015[992]
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy; Proteinuria in Nephrotic Range; Immunosuppressive Treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• End stage renal disease(ESRD)

  Two years

• Mortality

  Two years

Study Arms (3)

corticosteroid

pediatric IgA nephropathy treated with only corticosteroid

Drug: Corticosteroid; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonist

corticosteroid and cyclophosphamide

pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide

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

Drug: Corticosteroid; Drug: Mycophenolate mofetil; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonist

Interventions

Corticosteroid DRUG

Also known as: Steroid, Prednisone, Methylprednisone, Prednisolone, Deflazacort

corticosteroid; corticosteroid and cyclophosphamide; corticosteroid and mycophenolate mofetil

Cyclophosphamide DRUG

Also known as: CTX

corticosteroid and cyclophosphamide

Mycophenolate mofetil DRUG

Also known as: MMF

corticosteroid and mycophenolate mofetil

Dipyridamole DRUG

corticosteroid; corticosteroid and cyclophosphamide; corticosteroid and mycophenolate mofetil

ACE Inhibitor or Angiotensin receptor antagonist DRUG

corticosteroid; corticosteroid and cyclophosphamide; corticosteroid and mycophenolate mofetil

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.

Sponsors & Collaborators

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

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Adrenal Cortex Hormones; Steroids; Prednisone; Prednisolone; deflazacort; Cyclophosphamide; Mycophenolic Acid; Dipyridamole; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnadienetriols; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jie Ding, Prof.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuhui Zhong, Dr.

CONTACT

8613683556856; xuhui7876@126.com

Jie Ding, Prof.

CONTACT

861083573238; djnc_5855@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 10, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

CN (1)