Treatment of Stage 3 Chronic Kidney Disease with Huaiqihuang Granule

Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study

This study is testing if a new herbal treatment called Huaiqihuang Granule can help people with stage 3 chronic kidney disease caused by primary glomerulonephritis feel better compared to a standard medication.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 466 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Dalian Medical University (Academic / other)
• Locations: 34 sites (Beijing, Beijing Municipality and 33 other locations)
• Trial ID: NCT04263922 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Huaiqihuang Granule in patients diagnosed with primary glomerulonephritis at stage 3 of chronic kidney disease (CKD). It is a multicenter, randomized, double-blind, positive-drug parallel controlled trial involving approximately 466 participants across 40 hospitals. Participants will be divided into two groups, receiving either Huaiqihuang Granule or Valsartan for 48 weeks, with follow-up assessments at regular intervals to monitor outcomes. The study aims to address the lack of effective treatments for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with primary glomerulonephritis and experiencing stage 3 CKD.

Not a fit: Patients with secondary glomerulonephritis or those with significant comorbidities affecting kidney progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from primary glomerulonephritis at stage 3 CKD.

How similar studies have performed: Previous studies have indicated positive effects of Huaiqihuang Granule on primary glomerulonephritis, suggesting potential for success in this trial.

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

Where this trial is running

Beijing, Beijing Municipality and 33 other locations

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

Study contacts

• Principal investigator: Hongli Lin, MD — The First Affiliated Hospital of Dalian Medical University
• Study coordinator: Hongli Lin, MD

Conditions Renal Insufficiency, Chronic; Primary Glomerulonephritis; Huaiqihuang Granule; CKD3