An Early Phase 1 interventional study of Huaiqinhuang and valsartan in Henoch Schönlein Purpura Nephritis, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Status unknown at 2 sites in China. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Early Phase 1, Interventional, and Treatment
Among 16 studies in Purpura with a site in China — 4 open to participants now, 4 under way, 2 of them phase 3. Purpura · China.
Among the 16 studies in Purpura with a site in China, this one is the 14th largest by planned enrollment, is the only one that started in 2020, is the only one in phase 1, and was the 12th registered.
45 studies on the registry are indexed under Purpura; 4 are open to participants now.
Browse Purpura studies →4 of the 16 studies in Purpura with a site in China are open now. Recruiting first, the newest first:
Takeda · Sites in China, United States, Australia and 12 more countries
Capital Institute of Pediatrics, China · Sites in China
Takeda · Sites in China, United States, Australia and 15 more countries
CASI Pharmaceuticals, Inc. · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 4 Purpura studies recruiting now, 2 (50%) set no upper age limit and 2 (50%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 6 Years to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 11 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 79 across 34 interventional studies indexed under Purpura.
Median enrollment 137 across the 16 interventional studies. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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6 of 16 have an industry lead sponsor. The 9 most frequent:
The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
The Children's Hospital of Zhejiang University School of Medicine has 1 study filed under Purpura — fewer than ten, so there is no comparison to draw.
1 of the studies in Purpura with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07315191Capital Institute of Pediatrics, ChinaFinerenone Therapy for Pediatric HSPN With Mild Proteinuria | 2027-10-31 |
Among the 16 studies in Purpura with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Huaiqihuang granules 60g/1.73m2 bid 24 weeks
Drug: Huaiqinhuang
Valsartan granules 80mg/1.73m2 based qd 24 weeks
Drug: valsartan
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
Valsartan granules 80mg/1.73m2 based qd 24 weeks
Also known as: Valsartan capsule
change of urinary protein
24-hour urinary protein quantitative, urinary microprotein
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Change in renal function of the patients
blood chemistry
Time frame: 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.)
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
change of immunoglobulin + complement
immunoglobulin + complement
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
change of urine red blood cells
red blood cells routine urine
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Change of blood pressure
blood pressure
Time frame: 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)
Time frame: before Clinical trials; 1 month, 2 months, 3 months, 6 months after randomization
Plan to share: No — We could not share data without patients' agreement
No publications or documents are linked to this record.
Start is estimated for Nov 2020; primary completion for Aug 2021, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Valsartan
The Children's Hospital of Zhejiang University School of Medicine