Henoch Schönlein Purpura NephritisEarly Phase 1NCT04623866
Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
A Early Phase 1 study testing Huaiqinhuang and valsartan in people with Henoch Schönlein Purpura Nephritis, run by The Children's Hospital of Zhejiang University School of Medicine at 2 sites in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Henoch Schönlein Purpura Nephritis
- What is being tested?
- Huaiqinhuang and valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2020to 30 Aug 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Children Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Official title: 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.
Read the 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.
- Conditions
- Henoch Schönlein Purpura Nephritis
- Being tested
- Huaiqinhuang, valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuaiqinhuangDrug
Also called Huaiqihuang granules
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.
valsartanDrug
Also called Valsartan capsule
Valsartan granules 80mg/1.73m2 based qd 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Huaiqihuang Group | Active comparator | Huaiqihuang granules 60g/1.73m2 bid 24 weeks Receives: Drug: Huaiqinhuang |
| Valsartan group | Active comparator | Valsartan granules 80mg/1.73m2 based qd 24 weeks Receives: Drug: valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of urinary protein
24-hour urinary protein quantitative, urinary microprotein
Measured: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Change in renal function of the patients
blood chemistry
Measured: 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.)
Measured: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
change of immunoglobulin + complement
immunoglobulin + complement
Measured: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
change of urine red blood cells
red blood cells routine urine
Measured: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Secondary outcomes (2)
Change of blood pressure
blood pressure
Measured: 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)
Measured: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Henoch Schönlein Purpura NephritisStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Mao Jianhua, Study chair, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623866
- Sponsor's protocol ID
- CXPJJH12000003-202017
- Status last verified
- Nov 2020
- First submitted
- 25 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We could not share data without patients' agreement
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Randomized Controlled Clinical Study on the Treatment of Children With Purpura Nephritis With Huaiqihuang Granules
- ClinicalTrials.gov ID
- NCT04623866
- Acronym / sponsor ID
- CXPJJH12000003-202017
- Conditions
- Henoch Schönlein Purpura Nephritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaiqihuang Group | Active comparator | Drug: HuaiqinhuangHuaiqihuang granules 60g/1.73m2 bid 24 weeks |
| Valsartan group | Active comparator | Drug: valsartanValsartan granules 80mg/1.73m2 based qd 24 weeks |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuaiqinhuangAlso: Huaiqihuang granulesHuaiqihuang 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. | Drug | Huaiqihuang Group |
| valsartanAlso: Valsartan capsuleValsartan granules 80mg/1.73m2 based qd 24 weeks | Drug | Valsartan group |
Primary outcome
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
2 secondary outcomes
Change of blood pressure
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
change of BMI(Body Mass Index)
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No. We could not share data without patients' agreement
Related trials for Henoch Schönlein Purpura Nephritis
Recruiting
To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies
IgA Nephropathy (IgAN), Henoch Schönlein Purpura Nephritis
RecruitingPhase 3
Study of Ravulizumab in Pediatric Participants With Primary IgAN
IgAN, IgAVN
RecruitingPhase 4
Finerenone Therapy for Pediatric HSPN With Mild Proteinuria
Henoch Schönlein Purpura Nephritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mao Jianhua study chair
The Children's Hospital of Zhejiang University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Huaiqinhuang and valsartan in people with Henoch Schönlein Purpura Nephritis, run by The Children's Hospital of Zhejiang University School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mao Jianhua (13516819071, maojh88@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of urinary protein (time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.