Renal Insufficiency, Chronic
Conditions
Keywords
Primary Glomerulonephritis, Huaiqihuang Granule, CKD3
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.
Interventions
DRUGHuaiqihuang granules
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
DRUGValsartan capsule
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
Sponsors
Huazhong University of Science and Technology
LinkDoc Technology (Beijing) Co. Ltd.
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Start of treatment until the end of the treatment for 48 weeks | The proportion of patients with adverse events to the total population. |
| Incidence of adverse reactions | Start of treatment until the end of the treatment for 48 weeks | The proportion of patients with adverse reactions to the total population |
| Composite endpoint incidence | Start of treatment until the end of the treatment for 48 weeks | The incidence of endpoint events：① 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；② Serum creatinine doubles or enters maintenance of renal replacement therapy or death |
Countries
China
Contacts
Primary ContactHongli Lin, MD
Backup ContactDapeng Wang, MD
Outcome results
None listed