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

• ClinicalTrials.gov Identifier: NCT04623866
• Recruitment Status: Unknown
• First Posted: November 10, 2020
• Last Update Posted: November 10, 2020
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Information provided by (Responsible Party): Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine

Tracking Information

• First Submitted Date: October 25, 2020
• First Posted Date: November 10, 2020
• Last Update Posted Date: November 10, 2020
• Estimated Study Start Date: November 1, 2020
• Estimated Primary Completion Date: August 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2020)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 5, 2020)

• Change of blood pressure [ Time Frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization ]
  blood pressure
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Henoch Schönlein Purpura Nephritis

Intervention

• 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
• Drug: valsartan
  Valsartan granules 80mg/1.73m2 based qd 24 weeks
  Other Name: Valsartan capsule

Study Arms

• Active Comparator: Huaiqihuang Group
  Huaiqihuang granules 60g/1.73m2 bid 24 weeks
  Intervention: Drug: Huaiqinhuang
• Active Comparator: Valsartan group
  Valsartan granules 80mg/1.73m2 based qd 24 weeks
  Intervention: Drug: valsartan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 5, 2020): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2021
• Estimated Primary Completion Date: August 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04623866
• Other Study ID Numbers: CXPJJH12000003-202017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: We could not share data without patients' agreement

• Current Responsible Party: Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The Children's Hospital of Zhejiang University School of Medicine
• Verification Date: November 2020