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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623866
Recruitment Status : Unknown
Verified November 2020 by Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Henoch Schönlein Purpura Nephritis Drug: Huaiqinhuang Drug: valsartan Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

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 Name: 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 Name: Valsartan capsule




Primary Outcome Measures :
  1. change of urinary protein [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    24-hour urinary protein quantitative, urinary microprotein

  2. Change in renal function of the patients [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    blood chemistry

  3. change of lymphocyte subsets [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    including Th1 cells, Th2 cells, Th17 cells, cytokines (IL-16, IL-10, IL-17, etc.)

  4. change of immunoglobulin + complement [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    immunoglobulin + complement

  5. change of urine red blood cells [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    red blood cells routine urine


Secondary Outcome Measures :
  1. Change of blood pressure [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    blood pressure

  2. change of BMI(Body Mass Index) [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
    calculated by dividing weight in kilograms by height in meters squared( kg/m^2)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623866


Contacts
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Contact: Mao Jianhua 13516819071 maojh88@zju.edu.cn

Locations
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China, Zhejiang
The Children Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sponsors and Collaborators
The Children's Hospital of Zhejiang University School of Medicine
Investigators
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Study Chair: Mao Jianhua Children's Hospital, Zhejiang University School of Medicine
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Responsible Party: Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
ClinicalTrials.gov Identifier: NCT04623866    
Other Study ID Numbers: CXPJJH12000003-202017
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We could not share data without patients' agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Purpura, Schoenlein-Henoch
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Kidney Diseases
Urologic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action