Clinical trial NCT04623866: Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
Official title: A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Henoch Schönlein Purpura Nephritis
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Children of Purpura nephritis with moderate protenuria(24 hours urinary protein quantitative 0.5 \~ 1.0 1.73 g/m2 and 24 hours urinary protein amount of not more than 1.0 g) in this study was choosed as participatant, plan randomly into the group of 10 cases, treated with huaiqihuang particles and valsartan for 24 weeks to analyze the curative effect and clinical value of single drug therapy for children with purpura nephritis in reducing proteinuria, protecting renal function and promoting rehabilitation.

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.

Primary outcomes:
measure: change of urinary protein
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
measure: Change in renal function of the patients
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
measure: change of lymphocyte subsets
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
measure: change of immunoglobulin + complement
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
measure: change of urine red blood cells
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Secondary outcomes:
measure: Change of blood pressure
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
measure: change of BMI(Body Mass Index)
timeFrame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Children Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Children's Hospital, Zhejiang University School of Medicine
name: Mao Jianhua
role: STUDY_CHAIR
References: