Clinical trial NCT04263922: Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Keywords: Primary Glomerulonephritis
Huaiqihuang Granule
CKD3
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2020-02-11
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in serum creatinine levels from baseline
timeFrame: Start of treatment until the end of the treatment for 48 weeks
measure: Change in 24-hour urine protein ration from baseline.
timeFrame: Start of treatment until the end of the treatment for 48 weeks
measure: Changes in urine erythrocyte levels from baseline
timeFrame: Start of treatment until the end of the treatment for 48 weeks
Other outcomes:
measure: Composite endpoint incidence
timeFrame: Start of treatment until the end of the treatment for 48 weeks
measure: Incidence of adverse events
timeFrame: Start of treatment until the end of the treatment for 48 weeks
measure: Incidence of adverse reactions
timeFrame: Start of treatment until the end of the treatment for 48 weeks
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhangjiakou
country: China
facility: The First Affiliated Hospital of Hebei North University
state: Hebei
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial people's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology
state: Inner Mongolia
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou NO.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Anshan
country: China
facility: Anshan Central Hospital
state: Liaoning
city: Anshan
country: China
facility: Anshan Shuangshan Hospital
state: Liaoning
city: Anshan
country: China
facility: Ansteel Group General Hospital
state: Liaoning
city: Benxi
country: China
facility: Benxi Iron and Steel General Hospital of Liaoning Health Industry Group
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Dalian Ruikaier Nephropathy Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University( Huaxiang Area)
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Central Hospital affiliated to Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University (Nanhu Area)
state: Liaoning
city: Yingkou
country: China
facility: Yingkou Central Hospital
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia Hui Autonomous Region
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: The Sixth People's Hospital affiliated to Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine
state: Shanghai
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial people's Hospital
state: Shanxi
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Kunming
country: China
facility: Kunming Yan'an Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial people's Hospital
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Hongli Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: