Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3

NCT ID: NCT04263922

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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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

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Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Huaiqihuang group

Combine the use of Huaiqihuang granules and Valsartan capsule simulant.

Group Type EXPERIMENTAL

Huaiqihuang granules

Intervention Type DRUG

Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.

Valsartan Group

Combine the use of Valsartan capsule and Huaiqihuang granules simulant.

Group Type ACTIVE_COMPARATOR

Valsartan capsule

Intervention Type DRUG

Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.

Interventions

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Huaiqihuang granules

Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.

Intervention Type DRUG

Valsartan capsule

Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.

Intervention Type DRUG

Other Intervention Names

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B12000050755 H20030638

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed as primary glomerulonephritis by renal biopsy
2. Male or female, 18≤age≤65
3. Blood pressure can be effectively controlled at or below 140/90mmHg
4. 30mL/(min.1.73m2)≤ eGFR\<60mL/(min.1.73m2)
5. 24-hour urine protein ration ≤ 2.0g/24h
6. The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

Exclusion Criteria

1. Diagnosed as secondary glomerulonephritis
2. Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
3. Blood pressure \< 90/60 mmHg
4. Serum potassium \> 5.5 mmol/L
5. Serum albumin \< 30g/L
6. Unilateral or bilateral renal artery stenosis
7. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
8. Having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis, Diabetes, and Gout)
9. Allergic to the Huaiqihuang Granule or valsartan
10. Participating in another clinical trial
11. Investigators do not think it suitable for a participant to join this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongli Lin, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Locations

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Beijing Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China

Site Status RECRUITING

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Henan Provincial people's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

Site Status RECRUITING

Affiliated Hospital of Chifeng University

Chifeng, Inner Mongolia, China

Site Status RECRUITING

Changzhou NO.2 People's Hospital

Changzhou, Jiangsu, China

Site Status RECRUITING

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Anshan Central Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Anshan Shuangshan Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Ansteel Group General Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Benxi Iron and Steel General Hospital of Liaoning Health Industry Group

Benxi, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Dalian Ruikaier Nephropathy Hospital

Dalian, Liaoning, China

Site Status RECRUITING

Shengjing Hospital of China Medical University( Huaxiang Area)

Shenyang, Liaoning, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Central Hospital affiliated to Shenyang Medical College

Shenyang, Liaoning, China

Site Status RECRUITING

Shengjing Hospital of China Medical University (Nanhu Area)

Shenyang, Liaoning, China

Site Status RECRUITING

Yingkou Central Hospital

Yingkou, Liaoning, China

Site Status RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

The Sixth People's Hospital affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

Shanxi Provincial people's Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Kunming Yan'an Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Zhejiang Provincial people's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongli Lin, MD

Role: CONTACT

+86-13332268576

Dapeng Wang, MD

Role: CONTACT

+86-18098875653

Facility Contacts

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Yonghui Mao, MM

Role: primary

+86-13910913875

Ban Zhao, MM

Role: backup

+86-13910425475

Jianqin Wang, MD

Role: primary

+86-13919038189

Xiaochun Zhou, MM

Role: backup

+86-18393819911

Yunhua Liao, MM

Role: primary

+86-13878889238

Ling Pan, MD

Role: backup

+86-15296544109

Jinsheng Xu, MD

Role: primary

+86-13931116368

Yaling Bai, MD

Role: backup

+86-15081150811

Shengjun Liu, MB

Role: primary

+86-15530396533

Linlin Wang, MM

Role: backup

+86-15530396741

Jundong Jiao

Role: primary

+86-13845006919

Fengmin Shao, MM

Role: primary

+86-13607655698

Yan Miao, MM

Role: backup

+86-13849101887

Xiangcheng Xiao, MD

Role: primary

+86-13787312910

Ling Huang, MD

Role: backup

+86-15211043086

Caili Wang, MD

Role: primary

+86-13516723868

Yaqin Kang, MM

Role: backup

+86-15149387642

Xiaoyi Zhao, MM

Role: primary

+86-13947695080

Yongfeng Ci, MM

Role: backup

+86-15848997601

Tongqiang Liu, MD

Role: primary

+86-13775606952

Xiaoping Li, MD

Role: backup

+86-13915090077

Wei Sun, MD

Role: primary

+86-13505199810

Qing Li, MD

Role: backup

+86-13770503286

Hang Yuan, MD

Role: primary

17604307906

Dan Dong, MD

Role: backup

18243075191

Ping Luo, MD

Role: primary

+86-13596187651

Wenpeng Cui, MD

Role: backup

+86-13504316157

Wei Ding, MB

Role: primary

+86-18641215599

Xin Zhou, MM

Role: backup

13898055716

Cong Ma, MB

Role: primary

+86-13050031079

Ruiting Lv, MM

Role: backup

+86-13889721956

Na Yi, MM

Role: primary

+86-15164233397

Li Ma, MM

Role: backup

+86-15841203662

Huimin Wang, MM

Role: primary

+86-13942463528

Wei Wei, MM

Role: backup

15041492702

Hongli Lin, MD

Role: primary

+86-13332268576

Dapeng Wang, MD

Role: backup

+86-18098875653

Hua Xie, MD

Role: primary

+86-18098875657

Zhe Kang, MM

Role: backup

+86-13591330148

Hua Zhou, MD

Role: primary

+86-18611694286

Dajun Liu, MD

Role: backup

+86-18940251022

Li Yao, MD

Role: primary

+86-13904035673

Tianhua Xu, MM

Role: backup

+86-13998368056

Yi Sun, MM

Role: primary

+86-18002477026

Hua Zheng, MM

Role: backup

+86-13504182239

Dajun Liu

Role: primary

Yingchun Zhang, MM

Role: primary

+86-13050688336

Li Guo, MM

Role: backup

15504176643

Menghua Chen, MD

Role: primary

+86-13995083695

Xiangdong Yang, MD

Role: primary

+86-18560083856

Ling Guo, MD

Role: backup

+86-18560083860

Niansong Wang, MD

Role: primary

+86-13916328720

Guihua Jian, MM

Role: backup

+86-18930173172

Gengru Jiang, MD

Role: primary

+86-13816238339

Yingli Gu, MM

Role: backup

+86-13818695750

Lihua Wang, MD

Role: primary

+86-15234166600

Xinyan Liu, MD

Role: backup

+86-13803403221

Rongshan Lin, MD

Role: primary

+86-18734195439

Gaohong Liu, MD

Role: backup

+86-13834661591

Rong Li, MM

Role: primary

+86-13612058385

Kai Rong, MM

Role: backup

+86-13920187109

Jinwen Wang, MB

Role: primary

13700697545

Hao Chen, MM

Role: backup

13987665650

Qiang He, MD

Role: primary

+86-13588870088

Maosheng Chen, MD

Role: backup

+86-15868103636

Other Identifiers

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HQH-201911

Identifier Type: -

Identifier Source: org_study_id

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