Registry of IgA Nephropathy in Chinese Children

NCT03015974 — Unknown, 1200 participants, Peking University First Hospital
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03015974, acronym RACC
StatusUnknown
Study typeObservational
Enrollment1200 (Estimated)
SponsorPeking University First Hospital (Other); 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, The 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
ConditionsIgA Nephropathy, Proteinuria in Nephrotic Range, Immunosuppressive Treatment
InterventionsCorticosteroid, Cyclophosphamide, Mycophenolate mofetil, Dipyridamole, ACE Inhibitor or Angiotensin receptor antagonist (Drug)
Datesstart 2016-01-01, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2017-01-10, last updated 2023-12-06
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for IgA Nephropathy All trials for Proteinuria in Nephrotic Range All trials of Corticosteroid All trials of Cyclophosphamide

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
corticosteroidDrug: Corticosteroid; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with only corticosteroid
corticosteroid and cyclophosphamideDrug: Corticosteroid; Drug: Cyclophosphamide; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
corticosteroid and mycophenolate mofetilDrug: Corticosteroid; Drug: Mycophenolate mofetil; Drug: Dipyridamole; Drug: ACE Inhibitor or Angiotensin receptor antagonistpediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
  • Corticosteroid (Drug), also known as Steroid, Prednisone, Methylprednisone, Prednisolone, Deflazacort
  • Cyclophosphamide (Drug), also known as CTX
  • Mycophenolate mofetil (Drug), also known as MMF
  • Dipyridamole (Drug)
  • ACE Inhibitor or Angiotensin receptor antagonist (Drug)

+Outcome measures

Primary outcomes

  • Improvement of proteinuria [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 [Two years]: Renal dysfunction is defined as eGFR declined by more than 50%.
  • Hypertension [Two years]: Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 1 Month to 18 Years

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.

+Locations (1)

FacilityCityCountryStatus
Peking University First HospitalBeijingChinaRecruiting

+Investigators