Renal Insufficiency, ChronicPhase 4NCT04263922
Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3
A Phase 4 study testing Huaiqihuang granules and Valsartan capsule in people with Renal Insufficiency, Chronic, run by The First Affiliated Hospital of Dalian Medical University at 34 sites in China.
Trial summary
This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Huaiqihuang granules and Valsartan capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 34 sitesChina
- Study dates
- 30 Jun 2020to 30 Mar 2026
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as primary glomerulonephritis by renal biopsy
- Male or female, 18≤age≤65
- Blood pressure can be effectively controlled at or below 140/90mmHg
- 30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2）
- 24-hour urine protein ration ≤ 2.0g/24h
- The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Who cannot join
- Diagnosed as secondary glomerulonephritis
- Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
- Blood pressure < 90/60 mmHg
- Serum potassium > 5.5 mmol/L
- Serum albumin < 30g/L
- Unilateral or bilateral renal artery stenosis
Show all 11Show fewer
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- Having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis, Diabetes, and Gout)
- Allergic to the Huaiqihuang Granule or valsartan
- Participating in another clinical trial
- Investigators do not think it suitable for a participant to join this study
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Anshan Central Hospital
Anshan, Liaoning, 114000
Wei Ding, MB, +86-18641215599, Aszxdingwei@126.com
Xin Zhou, MM, 13898055716, zhouxin815@hotmail.com
- Recruiting
Anshan Shuangshan Hospital
Anshan, Liaoning, 114000
Cong Ma, MB, +86-13050031079, macong307@sina.com
Ruiting Lv, MM, +86-13889721956, lv_830826@163.com
- Recruiting
Ansteel Group General Hospital
Anshan, Liaoning, 114000
Na Yi, MM, +86-15164233397, yina710918@126.com
Li Ma, MM, +86-15841203662, luckylwhml@163.com
- Recruiting
The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 014010
Caili Wang, MD, +86-13516723868, Wangcaili213@163.com
Yaqin Kang, MM, +86-15149387642, 142496525@we.com
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Yonghui Mao, MM, +86-13910913875, Mmdn2009@163.com
Ban Zhao, MM, +86-13910425475, zbyule@139.com
- Recruiting
Benxi Iron and Steel General Hospital of Liaoning Health Industry Group
Benxi, Liaoning, 117000
Huimin Wang, MM, +86-13942463528, 307502752@qq.com
Wei Wei, MM, 15041492702, 974859394@qq.com
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
Hang Yuan, MD, 17604307906, hangyuan75@foxmail.com
Dan Dong, MD, 18243075191, sky-811@126.com
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130000
Ping Luo, MD, +86-13596187651, luopingjie@163.com
Wenpeng Cui, MD, +86-13504316157, wenpengcui@163.com
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xiangcheng Xiao, MD, +86-13787312910, 1376785378@qq.com
Ling Huang, MD, +86-15211043086, 767935151@qq.com
- Recruiting
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, 213000
Tongqiang Liu, MD, +86-13775606952, Liuyf1106@126.com
Xiaoping Li, MD, +86-13915090077, xiaopingandmax@163.com
- Recruiting
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, 024000
Xiaoyi Zhao, MM, +86-13947695080, zxy5080@163.com
Yongfeng Ci, MM, +86-15848997601, 67999124@qq.com
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 110001
Hongli Lin, MD, +86-13332268576, Linhongli@vip163.com
Dapeng Wang, MD, +86-18098875653, bobowdp@163.com
- Recruiting
Dalian Ruikaier Nephropathy Hospital
Dalian, Liaoning, 116021
Hua Xie, MD, +86-18098875657, wlciq007@163.com
Zhe Kang, MM, +86-13591330148, kz1107@163.com
- Recruiting
Zhejiang Provincial people's Hospital
Hangzhou, Zhejiang, 310014
Qiang He, MD, +86-13588870088, Strong_he@163.com
Maosheng Chen, MD, +86-15868103636, cms213@163.com
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Jundong Jiao, +86-13845006919, jiaojundong@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Xiangdong Yang, MD, +86-18560083856, yxd683@163.com
Ling Guo, MD, +86-18560083860, gulixiji@163.com
- Recruiting
Kunming Yan'an Hospital
Kunming, Yunnan, 650000
Jinwen Wang, MB, 13700697545, wjwyayy@163.com
Hao Chen, MM, 13987665650, 983553959@qq.com
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Jianqin Wang, MD, +86-13919038189, wangjianqin@medmail.com.cn
Xiaochun Zhou, MM, +86-18393819911, 1162377960@qq.com
- Recruiting
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210000
Wei Sun, MD, +86-13505199810, jssunwei@163.com
Qing Li, MD, +86-13770503286, 13770503286@163.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yunhua Liao, MM, +86-13878889238, yunhualiao1989@sina.com
Ling Pan, MD, +86-15296544109, nnpanling008@sina.com
- Recruiting
The Sixth People's Hospital affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200000
Niansong Wang, MD, +86-13916328720, wangniansong2012@163.com
Guihua Jian, MM, +86-18930173172, gh238@qq.com
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine
Shanghai, Shanghai Municipality, 200092
Gengru Jiang, MD, +86-13816238339, jianggeng-ru@hotmail.com
Yingli Gu, MM, +86-13818695750, yingli_gu666@163.com
- Recruiting
Shengjing Hospital of China Medical University( Huaxiang Area)
Shenyang, Liaoning, 110000
Hua Zhou, MD, +86-18611694286, 18611694286@163.com
Dajun Liu, MD, +86-18940251022, xpx200820@163.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110000
Li Yao, MD, +86-13904035673, liyao_cmu@163.com
Tianhua Xu, MM, +86-13998368056, xthhtq@sina.com
- Recruiting
Central Hospital affiliated to Shenyang Medical College
Shenyang, Liaoning, 110010
Yi Sun, MM, +86-18002477026, sunyi@medmail.com
Hua Zheng, MM, +86-13504182239, 24081306@qq.com
- Recruiting
Shengjing Hospital of China Medical University (Nanhu Area)
Shenyang, Liaoning
Dajun Liu
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jinsheng Xu, MD, +86-13931116368, xjs5766@126.com
Yaling Bai, MD, +86-15081150811, snbyl@163.com
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030013
Lihua Wang, MD, +86-15234166600, Lihuawang236@126.com
Xinyan Liu, MD, +86-13803403221, xinyanliu7011@163.com
- Recruiting
Shanxi Provincial people's Hospital
Taiyuan, Shanxi, 300012
Rongshan Lin, MD, +86-18734195439, rongshanli13@163.com
Gaohong Liu, MD, +86-13834661591, snowfox168408@126.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Rong Li, MM, +86-13612058385, beilloa@sohu.com
Kai Rong, MM, +86-13920187109, kevin342686691@126.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Menghua Chen, MD, +86-13995083695, nxchenmh@163.com
- Recruiting
Yingkou Central Hospital
Yingkou, Liaoning, 115000
Yingchun Zhang, MM, +86-13050688336, ykyc26@aliyun.com
Li Guo, MM, 15504176643, lilacgl@163.com
- Recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 050000
Shengjun Liu, MB, +86-15530396533, 15530396533@163.com
Linlin Wang, MM, +86-15530396741, 39012204@qq.com
- Recruiting
Henan Provincial people's Hospital
Zhengzhou, Henan, 450003
Fengmin Shao, MM, +86-13607655698, fengminshao@126.com
Yan Miao, MM, +86-13849101887, 153miaoyan@sina.com
About this study
Official title: Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study
This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.
Read the detailed description
Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Huaiqihuang granules, Valsartan capsule
- Keywords
- Primary Glomerulonephritis, Huaiqihuang Granule, CKD3
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaiqihuang granulesDrug
Also called B12000050755
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Valsartan capsuleDrug
Also called H20030638
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Huaiqihuang group | Experimental | Combine the use of Huaiqihuang granules and Valsartan capsule simulant. Receives: Drug: Huaiqihuang granules |
| Valsartan Group | Active comparator | Combine the use of Valsartan capsule and Huaiqihuang granules simulant. Receives: Drug: Valsartan capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
Measured: 48 weeks
Secondary outcomes (3)
Change in serum creatinine levels from baseline
Serum creatinine is being assessed once every 8 weeks for a total of 6 times during the whole study
Measured: Start of treatment until the end of the treatment for 48 weeks
Change in 24-hour urine protein ration from baseline.
Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study
Measured: Start of treatment until the end of the treatment for 48 weeks
Changes in urine erythrocyte levels from baseline
Urine erythrocyte is being assessed once every 8 weeks for a total of 6 times during the whole study
Measured: Start of treatment until the end of the treatment for 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start30 Jun 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Hongli Lin, MD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263922
- Sponsor's protocol ID
- HQH-201911
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2019
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT04263922
- Acronym / sponsor ID
- HQH-201911
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Primary Glomerulonephritis, Huaiqihuang Granule, CKD3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 11 Feb 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.
This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.
Detailed description
Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaiqihuang group | Experimental | Drug: Huaiqihuang granulesCombine the use of Huaiqihuang granules and Valsartan capsule simulant. |
| Valsartan Group | Active comparator | Drug: Valsartan capsuleCombine the use of Valsartan capsule and Huaiqihuang granules simulant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed as primary glomerulonephritis by renal biopsy
- Male or female, 18≤age≤65
- Blood pressure can be effectively controlled at or below 140/90mmHg
- 30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2）
- 24-hour urine protein ration ≤ 2.0g/24h
Key exclusion criteria (11 listed)
- Diagnosed as secondary glomerulonephritis
- Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
- Blood pressure < 90/60 mmHg
- Serum potassium > 5.5 mmol/L
- Serum albumin < 30g/L
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 |
|---|---|---|
| Huaiqihuang granulesAlso: B12000050755Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration. | Drug | Huaiqihuang group |
| Valsartan capsuleAlso: H20030638Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration. | Drug | Valsartan Group |
Primary outcome
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Time frame: 48 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
3 secondary outcomes
Change in serum creatinine levels from baseline
Time frame: Start of treatment until the end of the treatment for 48 weeks
Change in 24-hour urine protein ration from baseline.
Time frame: Start of treatment until the end of the treatment for 48 weeks
Changes in urine erythrocyte levels from baseline
Time frame: Start of treatment until the end of the treatment for 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hongli Lin, MD principal investigator
The First Affiliated Hospital of Dalian Medical University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaiqihuang granules and Valsartan capsule in people with Renal Insufficiency, Chronic, run by The First Affiliated Hospital of Dalian Medical University at 34 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 6 inclusion and 11 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hongli Lin, MD (+86-13332268576, linhongli@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline (time frame: 48 weeks). 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 12 Jul 2024.