Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Huaiqihuang granules
* Drug: Valsartan capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as primary glomerulonephritis by renal biopsy Male or female, 18≤age≤65 Blood pressure can be effectively controlled at or below 140/90mmHg 30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2） 24-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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaiqihuang group<br>Combine the use of Huaiqihuang granules and Valsartan capsule simulant. | Drug: Huaiqihuang granules<br>* Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.<br>* Other names: B12000050755;|
| Active Comparator: Valsartan Group<br>Combine the use of Valsartan capsule and Huaiqihuang granules simulant. | Drug: Valsartan capsule<br>* Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.<br>* Other names: H20030638;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Glomerulonephritis, Huaiqihuang Granule, CKD3