Trial | NCT04263922  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    466
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.
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 Started
Jun 30
2020
Primary Completion
Oct 31
2025
Anticipated
Study Completion
Mar 30
2026
Anticipated
Last Update
Jun 15
2023

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.

  • Other names: B12000050755

Drug 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.

  • Other names: H20030638

Huaiqihuang group Experimental

Combine the use of Huaiqihuang granules and Valsartan capsule simulant.

Valsartan Group Active Comparator

Combine the use of Valsartan capsule and Huaiqihuang granules simulant.

Criteria 

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
No Results Posted