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

NCT04623866 | Unknown Early Phase 1

• 1 other identifier: CXPJJH12000003-202017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Henoch Schönlein Purpura Nephritis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change of blood pressure

  before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization

• change of BMI(Body Mass Index)

  before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization

Study Arms (2)

Huaiqihuang Group

ACTIVE COMPARATOR

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

Drug: Huaiqinhuang

Valsartan group

ACTIVE COMPARATOR

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Drug: valsartan

Interventions

Huaiqinhuang DRUG

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.

Also known as: Huaiqihuang granules

Huaiqihuang Group

valsartan DRUG

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Also known as: Valsartan capsule

Valsartan group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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);
• Age: 6-14 years old;
• Normal renal function: eGFR≥90ml/min/1.73m2;
• 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.

You may not qualify if:

• Abnormal ophthalmic examination (fundus, visual field, photosensitivity);
• Combined with gross hematuria;
• Serious diseases of the heart, liver and other important organs, as well as diseases of the blood and endocrine system;
• Patients who are known to be allergic to any component of Locust and wolfberry yellow or ACEI/ARB;
• Patients who have participated in other clinical trials within three months before enrollment;
• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (2)

The Children Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Valsartan

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Mao Jianhua

  Children's Hospital, Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Mao Jianhua

CONTACT

13516819071; maojh88@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Children's Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 10, 2020
• Study Start: November 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 30, 2021
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)