Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules

Zhejiang University

Status and phase: Unknown; Early Phase 1

Conditions: Henoch Schönlein Purpura Nephritis

Treatments: Drug: valsartan; Drug: Huaiqinhuang

Study type: Interventional

Funder types: Other

Identifiers

NCT04623866

CXPJJH12000003-202017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups

Huaiqihuang Group

Active Comparator group

Description:

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

Treatment:

Drug: Huaiqinhuang

Valsartan group

Active Comparator group

Description:

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Treatment:

Drug: valsartan