Diabetic Nephropathies
Conditions
Keywords
Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
Brief summary
This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.
Detailed description
The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.
Interventions
Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.
DRUGDapagliflozin
Dapagliflozin, 10mg at a time, once a day. Oral administration.
Sponsors
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed as diabetic nephropathy 2. TCM syndrome differentiation is Qi deficiency and blood stasis type 3. Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR\<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h 6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Exclusion criteria
1. Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period 2. Urinary tract infection (leukocytes in urinary sediment \> 5 / HP) 3. Serum potassium \> 5.5 mmol/L 4. Serum albumin \< 30g/L 5. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period 6. Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis) 7. Participating in another clinical trial 8. 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 | 12 weeks | Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour urine protein ration from baseline. | Start of treatment until the end of the treatment for 12 weeks | 24-hour urinary protein quantification is being assessed once every 4 weeks for a total of 4 times during the whole study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint incidence | Start of treatment until the end of the treatment for 12 weeks | The incidence of endpoint events：① eGFR decreased by 15% from baseline；② The incidence of doubling the quantitative change of 24-hour urinary protein (measured twice continuously). |
| Incidence of adverse reactions | Start of treatment until the end of the treatment for 12 weeks | The proportion of patients with adverse reactions to the total population |
Countries
China
Outcome results
None listed