Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis

Renal Insufficiency, Chronic Clinical Trial

Official title:

Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis: A Multicentre Prospective, Randomized, Double-blind and Imitation, Positive-drug Parallel Controlled Clinical Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263922
• Other study ID #: HQH-201911
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: March 30, 2026

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Hongli Lin, MD
• Phone: +86-13332268576
• Email: linhongli[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 466
• Est. completion date: March 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Anshan Central Hospital	Anshan	Liaoning
China	Anshan Shuangshan Hospital	Anshan	Liaoning
China	Ansteel Group General Hospital	Anshan	Liaoning
China	The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia
China	Beijing Hospital	Beijing	Beijing
China	Benxi Iron and Steel General Hospital of Liaoning Health Industry Group	Benxi	Liaoning
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou NO.2 People's Hospital	Changzhou	Jiangsu
China	Affiliated Hospital of Chifeng University	Chifeng	Inner Mongolia
China	Dalian Ruikaier Nephropathy Hospital	Dalian	Liaoning
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Zhejiang Provincial people's Hospital	Hangzhou	Zhejiang
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Kunming Yan'an Hospital	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The Sixth People's Hospital affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of medicine	Shanghai	Shanghai
China	Central Hospital affiliated to Shenyang Medical College	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University (Nanhu Area)	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University( Huaxiang Area)	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Provincial people's Hospital	Taiyuan	Shanxi
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Yingkou Central Hospital	Yingkou	Liaoning
China	The First Affiliated Hospital of Hebei North University	Zhangjiakou	Hebei
China	Henan Provincial people's Hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University	Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite endpoint incidence	The incidence of endpoint events:? eGFR 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;? Serum creatinine doubles or enters maintenance of renal replacement therapy or death	Start of treatment until the end of the treatment for 48 weeks
Other	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
Other	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
Primary	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	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
Secondary	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	Start of treatment until the end of the treatment for 48 weeks
Secondary	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