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 : April 22, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 2023 |
Estimated Study Completion Date : | June 2023 |

Group/Cohort | Intervention/treatment |
---|---|
corticosteroid
pediatric IgA nephropathy treated with only corticosteroid
|
Drug: Corticosteroid
Other Names:
Drug: Dipyridamole Drug: ACE Inhibitor or Angiotensin receptor antagonist |
corticosteroid and cyclophosphamide
pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide
|
Drug: Corticosteroid
Other Names:
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:
Drug: Mycophenolate mofetil Other Name: MMF Drug: Dipyridamole Drug: ACE Inhibitor or Angiotensin receptor antagonist |
- 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.
- 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

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.
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 |
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.

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
Contact: Xuhui Zhong, Dr. | 8613683556856 | xuhui7876@126.com | |
Contact: Jie Ding, Prof. | 861083573238 | djnc_5855@126.com |
China | |
Peking University First Hospital | Recruiting |
Beijing, China, 100034 | |
Contact: Xuhui Zhong, Dr. 8613683556856 xuhui7876@126.com |
Principal Investigator: | Jie Ding, Prof. | Peking University First Hospital |
Responsible Party: | Jie Ding, Prof., Peking University First Hospital |
ClinicalTrials.gov Identifier: | NCT03015974 |
Other Study ID Numbers: |
2015[992] |
First Posted: | January 10, 2017 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Kidney Diseases Proteinuria Glomerulonephritis, IGA Urologic Diseases Urination Disorders Urological Manifestations Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Mycophenolic Acid Prednisone Prednisolone Deflazacort Cyclophosphamide |
Dipyridamole Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones |