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| Name | Class |
|---|---|
| Huazhong University of Science and Technology | OTHER |
| LinkDoc Technology (Beijing) Co. Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huaiqihuang group | Experimental | Combine the use of Huaiqihuang granules and Valsartan capsule simulant. |
|
| Valsartan Group | Active Comparator | Combine the use of Valsartan capsule and Huaiqihuang granules simulant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaiqihuang granules | Drug | Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Start of treatment until the end of the treatment for 48 weeks |
| Change in 24-hour urine protein ration from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint incidence | The incidence of endpoint events:①eGFR decreased by 15% from baseline and was reviewed within 2 weeks, if no improvement was found or if the eGFR continued to decrease by 15% below baseline;② Serum creatinine doubles or enters maintenance of renal replacement therapy or death | Start of treatment until the end of the treatment for 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Lin, MD | Contact | +86-13332268576 | linhongli@vip.163.com | |
| Dapeng Wang, MD | Contact | +86-18098875653 | bobowdp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongli Lin, MD | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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|
| Valsartan capsule | Drug | Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration. |
|
|
Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study |
| 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 | Start of treatment until the end of the treatment for 48 weeks |
| Incidence of adverse events | The proportion of patients with adverse events to the total population. | Start of treatment until the end of the treatment for 48 weeks |
| Incidence of adverse reactions | The proportion of patients with adverse reactions to the total population | Start of treatment until the end of the treatment for 48 weeks |
| Lanzhou University Second Hospital | Recruiting | Lanzhou | Gansu | 730030 | China |
|
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
|
| The First Affiliated Hospital of Hebei North University | Recruiting | Zhangjiakou | Hebei | 050000 | China |
|
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
|
| Henan Provincial people's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
|
| The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology | Recruiting | Baotou | Inner Mongolia | 014010 | China |
|
| Affiliated Hospital of Chifeng University | Recruiting | Chifeng | Inner Mongolia | 024000 | China |
|
| Changzhou NO.2 People's Hospital | Recruiting | Changzhou | Jiangsu | 213000 | China |
|
| Jiangsu Province Hospital of Chinese Medicine | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
|
| The Second Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
|
| Anshan Central Hospital | Recruiting | Anshan | Liaoning | 114000 | China |
|
| Anshan Shuangshan Hospital | Recruiting | Anshan | Liaoning | 114000 | China |
|
| Ansteel Group General Hospital | Recruiting | Anshan | Liaoning | 114000 | China |
|
| Benxi Iron and Steel General Hospital of Liaoning Health Industry Group | Recruiting | Benxi | Liaoning | 117000 | China |
|
| The First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 110001 | China |
|
| Dalian Ruikaier Nephropathy Hospital | Recruiting | Dalian | Liaoning | 116021 | China |
|
| Shengjing Hospital of China Medical University( Huaxiang Area) | Recruiting | Shenyang | Liaoning | 110000 | China |
|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
|
| Central Hospital affiliated to Shenyang Medical College | Recruiting | Shenyang | Liaoning | 110010 | China |
|
| Shengjing Hospital of China Medical University (Nanhu Area) | Recruiting | Shenyang | Liaoning | China |
|
| Yingkou Central Hospital | Recruiting | Yingkou | Liaoning | 115000 | China |
|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
|
| The Sixth People's Hospital affiliated to Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
|
| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030013 | China |
|
| Shanxi Provincial people's Hospital | Recruiting | Taiyuan | Shanxi | 300012 | China |
|
| The Second Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | 300211 | China |
|
| Kunming Yan'an Hospital | Recruiting | Kunming | Yunnan | 650000 | China |
|
| Zhejiang Provincial people's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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