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

Primary Purpose

Henoch Schönlein Purpura Nephritis

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Huaiqinhuang

valsartan

About this trial

This is an interventional treatment trial for Henoch Schönlein Purpura Nephritis

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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);
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.

Exclusion Criteria:

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.

Sites / Locations

The Children Hospital of Zhejiang University School of Medicine
Children's Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Huaiqihuang Group

Valsartan group

Arm Description

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Outcomes

Primary Outcome Measures

change of urinary protein

24-hour urinary protein quantitative, urinary microprotein

Change in renal function of the patients

blood chemistry

change of lymphocyte subsets

including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.)

change of immunoglobulin + complement

immunoglobulin + complement

change of urine red blood cells

red blood cells routine urine

Secondary Outcome Measures

Change of blood pressure

blood pressure

change of BMI(Body Mass Index)

calculated by dividing weight in kilograms by height in meters squared( kg/m^2)

Full Information

NCT ID

NCT04623866

First Posted

October 25, 2020

Last Updated

November 5, 2020

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04623866

Brief Title

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

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Anticipated)

Primary Completion Date

August 1, 2021 (Anticipated)

Study Completion Date

August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Children's Hospital of Zhejiang University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Henoch Schönlein Purpura Nephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huaiqihuang Group

Arm Type

Active Comparator

Arm Description

Huaiqihuang granules 60g/1.73m2 bid 24 weeks

Arm Title

Valsartan group

Arm Type

Active Comparator

Arm Description

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Intervention Type

Drug

Intervention Name(s)

Huaiqinhuang

Other Intervention Name(s)

Huaiqihuang granules

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

valsartan

Other Intervention Name(s)

Valsartan capsule

Intervention Description

Valsartan granules 80mg/1.73m2 based qd 24 weeks

Primary Outcome Measure Information:

Title

change of urinary protein

Description

24-hour urinary protein quantitative, urinary microprotein

Time Frame

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

Title

Change in renal function of the patients

Description

blood chemistry

Time Frame

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

Title

change of lymphocyte subsets

Description

including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.)

Time Frame

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

Title

change of immunoglobulin + complement

Description

immunoglobulin + complement

Time Frame

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

Title

change of urine red blood cells

Description

red blood cells routine urine

Time Frame

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

Secondary Outcome Measure Information:

Title

Change of blood pressure

Description

blood pressure

Time Frame

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

Title

change of BMI(Body Mass Index)

Description

calculated by dividing weight in kilograms by height in meters squared( kg/m^2)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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); 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mao Jianhua

Phone

13516819071

maojh88@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mao Jianhua

Organizational Affiliation

Children's Hospital, Zhejiang University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

The Children Hospital of Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Facility Name

Children's Hospital, Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We could not share data without patients' agreement

Learn more about this trial

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

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