Clinical trial NCT05418465: Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy
Official title: A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathies
Keywords: Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in 24-hour urine protein ration from baseline.
timeFrame: Start of treatment until the end of the treatment for 12 weeks
Other outcomes:
measure: Composite endpoint incidence
timeFrame: Start of treatment until the end of the treatment for 12 weeks
measure: Incidence of adverse reactions
timeFrame: Start of treatment until the end of the treatment for 12 weeks
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian medical university
state: Liaoning
Study officials:
References: