Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy

Not Applicable

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Huangqi Guizhi Wuwu decoction; Drug: Dapagliflozin

• Registration Number: NCT05418465
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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.

Study Timeline

• Study Start: 2022-01-26
• Status Verified: 2022-06
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Last Update Submitted: 2022-06-10
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huangqi Guizhi Wuwu decoction group	Huangqi Guizhi Wuwu decoction	Huangqi Guizhi Wuwu decoction
Dapagliflozin group	Dapagliflozin	Dapagliflozin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian medical university; 🇨🇳 Dalian, Liaoning, China