Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3

Phase 4

Recruiting

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Valsartan capsule; Drug: Huaiqihuang granules

• Registration Number: NCT04263922
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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.

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2020-02-08
• Study First Posted: 2020-02-11
• Study Start: 2020-06-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-10-31
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 466

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan Group	Valsartan capsule	Combine the use of Valsartan capsule and Huaiqihuang granules simulant.
Huaiqihuang group	Huaiqihuang granules	Combine the use of Huaiqihuang granules and Valsartan capsule simulant.

Primary Outcome Measures

Name	Time	Method
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline	48 weeks	Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.

Secondary Outcome Measures

Name	Time	Method
Change in 24-hour urine protein ration from baseline.	Start of treatment until the end of the treatment for 48 weeks	Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study
Change in serum creatinine levels from baseline	Start of treatment until the end of the treatment for 48 weeks	Serum creatinine is being assessed once every 8 weeks for a total of 6 times during the whole study
Changes in urine erythrocyte levels from baseline	Start of treatment until the end of the treatment for 48 weeks	Urine erythrocyte is being assessed once every 8 weeks for a total of 6 times during the whole study

Trial Locations

Locations (34)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital of Hebei North University; 🇨🇳 Zhangjiakou, Hebei, China

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Henan Provincial people's Hospital; 🇨🇳 Zhengzhou, Henan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology; 🇨🇳 Baotou, Inner Mongolia, China

Affiliated Hospital of Chifeng University; 🇨🇳 Chifeng, Inner Mongolia, China

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