Nephrotic SyndromeNCT03332420
The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
An observational study of Nephrotic Syndrome, run by Qidong Gaitianli Medicines Co., Ltd at 17 sites in China.
Trial summary
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Nephrotic Syndrome
- How many people
- 1,507 participants
- Where
- 17 sitesChina
- Study dates
- 16 Nov 2017to 31 Aug 2021
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children are diagnosed with primary nephrotic syndrome
Who may be able to join
- In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
- Age from 1 to18;
- ALT and AST levels do not exceed twice the upper limit of the normal range;;
- Provision of written informed consent by legal guardians.
Who cannot join
- a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
- History of diabetes or examinations showed elevated blood glucose levels;
- Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
- Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
- Patients who are unlikely to adhere to the protocol.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Children's Hospital Capital Institute Of Pediatrics
Beijing, Beijing Municipality, 100020
The first Bethune Hospital of Jilin University
Changchun, Jilin
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Children's Hospital of Chongqing Medical University
Chongqing
Harbin Children's Hospital
Harbin, Heilongjiang
Jiangxi Provincal Children's Hospital
Nanchang, Jiangxi
Benq Medical Center
Nanjing, Jiangsu
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu
Children's Hospital of Soochow University
Suzhou, Jiangsu
Children's Hospital of Shanxi
Taiyuan, Shanxi
Tianjin Children's Hospital
Tianjin
Urumqi first people's Hospital
Ürümqi, Xinjiang
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan
Wuxi Children's Hospital
Wuxi, Jiangsu
Xuzhou Children's Hospital
Xuzhou, Jiangsu
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Henan Children's Hospital
Zhengzhou, Henan
About this study
Official title: A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
Read the detailed description
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
- Conditions
- Nephrotic Syndrome
- Keywords
- Huaiqihuang granule, primary nephrotic syndrome, multisite, prospective, open-label
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational 1 | Huaiqihuang Granule | |
| Observational 2 | Standard treatment+Huaiqihuang Granule | |
| Observational 3 | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of positive urine protein test changing to the negative result
Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
Measured: 48 weeks after treatment
The ratio of positive to negative urine protein
The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
Measured: 48 Weeks after treatment
The decrease of 24-hour urine protein level
Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks.
Measured: 48 Weeks after treatment
Secondary outcomes (3)
Recovery of blood albumin levels
Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks.
Measured: 48 Weeks after treatment
Recurrence rate of PNS
The proportion of recurrent subjects to the total number of subjects.
Measured: 48 Weeks after treatment
Rates of infectious complications of PNS
The proportion of complicated infectious subjects to the total number of subjects.
Measured: 48 Weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start16 Nov 2017
- Primary completion21 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Capital Institute of Pediatrics, China
- Responsible party
- Sponsor
- Investigators
- Chaoying Chen, Professor, Principal investigator, Children's Hospital of The Capital Institute of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332420
- Sponsor's protocol ID
- HQH-201705
- Status last verified
- Dec 2022
- First submitted
- 15 Oct 2017
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT03332420
- Acronym / sponsor ID
- HQH-201705
- Conditions
- Nephrotic Syndrome
- Keywords
- Huaiqihuang granule, primary nephrotic syndrome, multisite, prospective, open-label
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- Qidong Gaitianli Medicines Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Capital Institute of Pediatrics, China
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Nov 2017 (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.
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
Detailed description
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational 1 | – | –Huaiqihuang Granule |
| Observational 2 | – | –Standard treatment+Huaiqihuang Granule |
| Observational 3 | – | –Standard treatment |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children are diagnosed with primary nephrotic syndrome
Key inclusion criteria (4 listed)
- In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
- Age from 1 to18;
- ALT and AST levels do not exceed twice the upper limit of the normal range;;
- Provision of written informed consent by legal guardians.
Key exclusion criteria (6 listed)
- a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
- History of diabetes or examinations showed elevated blood glucose levels;
- Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
- Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of positive urine protein test changing to the negative result
Time frame: 48 weeks after treatment
Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
The ratio of positive to negative urine protein
Time frame: 48 Weeks after treatment
The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
The decrease of 24-hour urine protein level
Time frame: 48 Weeks after treatment
Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks.
3 secondary outcomes
Recovery of blood albumin levels
Time frame: 48 Weeks after treatment
Recurrence rate of PNS
Time frame: 48 Weeks after treatment
Rates of infectious complications of PNS
Time frame: 48 Weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Chaoying Chen, Professor principal investigator
Children's Hospital of The Capital Institute of Pediatrics
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by Qidong Gaitianli Medicines Co., Ltd at 17 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 4 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: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of positive urine protein test changing to the negative result (time frame: 48 weeks after treatment). The study lists 3 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 22 Dec 2022.