Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT04623866
Eligibility Criteria:
Inclusion Criteria:
1. For children diagnosed with purpura nephritis, the diagnostic criteria for purpura nephritis shall refer to the 2016 edition of Evidence-based Guideline for diagnosis and Treatment of Purpura Nephritis published by the Nephrology Group of The Chinese Medical Association Pediatrics Branch, specifically as follows: Hematuria and/or proteinuria occur within 6 months of the course of allergic purpura. The diagnostic criteria for hematuria and proteinuria are as follows: A. Hematuria: gross hematuria or ≥3 RBC/high-power field (HP) under 3 times of microscope within 1 week. B. Proteinuria: if meeting any of the following conditions: 3 routine urine tests within 1 week qualitatively indicate positive urine protein; 24h quantitative urine protein \>150 mg or urine protein/creatinine (mg/mg)\>0.2; Urinary microalbumin was higher than normal for 3 times within 1 week. Very few children in the acute course of allergic purpura 6 months later, recurrent purpura, hematuria and/or proteinuria for the first time, should be sought for renal biopsy, such as IgA mesangial mesangial proliferative glomerulonephritis, can still be diagnosed as purpura nephritis.
2. 24-hour urinary protein quantification of 0.5 to 1.0g/1.73m2, and the total amount does not exceed 1.0g (to be quantified in non-infectious conditions);
3. Age: 6-14 years old;
4. Normal renal function: eGFR≥90ml/min/1.73m2;
5. Other manifestations of allergic purpura: skin purpura, abdominal pain, blood stool and joint swelling and pain have been relieved, and the use of hormone or immunosuppressive agents has been stopped for 2 weeks.
Exclusion Criteria:
1. Abnormal ophthalmic examination (fundus, visual field, photosensitivity);
2. Combined with gross hematuria;
3. Serious diseases of the heart, liver and other important organs, as well as diseases of the blood and endocrine system;
4. Patients who are known to be allergic to any component of Locust and wolfberry yellow or ACEI/ARB;
5. Patients who have participated in other clinical trials within three months before enrollment;
6. The investigator judged that the patient was not fit to participate in the study;(7) renal purpura nephritis wear results indicate Ⅲ magnitude or hints chronic purpura nephritis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT04623866
Study Brief:
Protocol Section:
NCT04623866