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

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.

Study Overview

• Status: Unknown
• Conditions: Henoch Schönlein Purpura Nephritis
• Intervention / Treatment: Drug: Huaiqinhuang; Drug: valsartan

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mao Jianhua; Phone Number: 13516819071; Email: maojh88@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The Children Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Children's Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Huaiqihuang Group; Huaiqihuang granules 60g/1.73m2 bid 24 weeks	Drug: Huaiqinhuang; Huaiqihuang granules are composed of Huaier fungus, Fructus lycii and Huangjing. Studies have shown that huaiqihuang treatment can reduce cytokines in children with purpura nephritis interleukins IL - 4, IL - 10 and the tumor necrosis factor alpha (TNF alpha) expression level, prompt huaiqihuang granule treating children allergic purpura nephritis can significantly improve the clinical curative effect, improve the level of cytokines and the patient's immune function, and does not increase the incidence of adverse reactions.; Other Names: Huaiqihuang granules
Active Comparator: Valsartan group; Valsartan granules 80mg/1.73m2 based qd 24 weeks	Drug: valsartan; Valsartan granules 80mg/1.73m2 based qd 24 weeks; Other Names: Valsartan capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of urinary protein	24-hour urinary protein quantitative, urinary microprotein	before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Change in renal function of the patients	blood chemistry	before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
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
change of immunoglobulin + complement	immunoglobulin + complement	before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of blood pressure	blood pressure	before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
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

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Investigators: Study Chair: Mao Jianhua, Children's Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Hemostatic Disorders; Vasculitis; Hypersensitivity; Blood Coagulation Disorders; Skin Manifestations; Immune Complex Diseases; Purpura; Nephritis; Purpura, Schoenlein-Henoch; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: CXPJJH12000003-202017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We could not share data without patients' agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No