Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3
Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study
1 other identifier
interventional
466
1 country
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2020
Longer than P75 for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedJuly 12, 2024
June 1, 2024
5.3 years
December 3, 2019
July 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change in serum creatinine levels from baseline
Start of treatment until the end of the treatment for 48 weeks
Change in 24-hour urine protein ration from baseline.
Start of treatment until the end of the treatment for 48 weeks
Changes in urine erythrocyte levels from baseline
Start of treatment until the end of the treatment for 48 weeks
Other Outcomes (3)
Composite endpoint incidence
Start of treatment until the end of the treatment for 48 weeks
Incidence of adverse events
Start of treatment until the end of the treatment for 48 weeks
Incidence of adverse reactions
Start of treatment until the end of the treatment for 48 weeks
Study Arms (2)
Huaiqihuang group
EXPERIMENTALCombine the use of Huaiqihuang granules and Valsartan capsule simulant.
Valsartan Group
ACTIVE COMPARATORCombine the use of Valsartan capsule and Huaiqihuang granules simulant.
Interventions
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
Eligibility Criteria
You may qualify if:
- Diagnosed as primary glomerulonephritis by renal biopsy
- Male or female, 18≤age≤65
- Blood pressure can be effectively controlled at or below 140/90mmHg
- mL/（min.1.73m2）≤ eGFR\<60mL/（min.1.73m2）
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 050000, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Henan Provincial people's Hospital
Zhengzhou, Henan, 450003, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia, 014010, China
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, 024000, China
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, 213000, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210000, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
Anshan Central Hospital
Anshan, Liaoning, 114000, China
Anshan Shuangshan Hospital
Anshan, Liaoning, 114000, China
Ansteel Group General Hospital
Anshan, Liaoning, 114000, China
Benxi Iron and Steel General Hospital of Liaoning Health Industry Group
Benxi, Liaoning, 117000, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 110001, China
Dalian Ruikaier Nephropathy Hospital
Dalian, Liaoning, 116021, China
Shengjing Hospital of China Medical University( Huaxiang Area)
Shenyang, Liaoning, 110000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Central Hospital affiliated to Shenyang Medical College
Shenyang, Liaoning, 110010, China
Shengjing Hospital of China Medical University (Nanhu Area)
Shenyang, Liaoning, China
Yingkou Central Hospital
Yingkou, Liaoning, 115000, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
The Sixth People's Hospital affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200000, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine
Shanghai, Shanghai Municipality, 200092, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030013, China
Shanxi Provincial people's Hospital
Taiyuan, Shanxi, 300012, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Kunming Yan'an Hospital
Kunming, Yunnan, 650000, China
Zhejiang Provincial people's Hospital
Hangzhou, Zhejiang, 310014, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongli Lin, MD
The First Affiliated Hospital of Dalian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2019
First Posted
February 11, 2020
Study Start
June 30, 2020
Primary Completion
October 31, 2025
Study Completion
March 30, 2026
Last Updated
July 12, 2024
Record last verified: 2024-06