Henoch Schönlein Purpura Nephritis Clinical Trial
Official title:
A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
About 20% children with allergic purpura develop nephritis syndrome or nephrotic syndrome, 1% to 7% to kidney failure or end-stage renal disease. Children with serious damage to health, significantly reduced quality of life and caused heavy economic burden to the family . As the pathogenesis of HSPN is complex, it is difficult to formulate an exact individualized treatment plan.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | August 30, 2021 |
| Est. primary completion date | August 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 14 Years |
| Eligibility | 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 ? magnitude or hints chronic purpura nephritis. |
| Country | Name | City | State |
|---|---|---|---|
| China | Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | The Children Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| The Children's Hospital of Zhejiang University School of Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of urinary protein | 24-hour urinary protein quantitative, urinary microprotein | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Primary | Change in renal function of the patients | blood chemistry | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Primary | change of lymphocyte subsets | including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.) | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Primary | change of immunoglobulin + complement | immunoglobulin + complement | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Primary | change of urine red blood cells | red blood cells routine urine | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Secondary | Change of blood pressure | blood pressure | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization | |
| Secondary | change of BMI(Body Mass Index) | calculated by dividing weight in kilograms by height in meters squared( kg/m^2) | before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization |