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

Diabetic Nephropathies Clinical Trial

Official title:

A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418465
• Other study ID #: PJ-KS-KY-2021-228(X2)
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Huangqi Guizhi Wuwu decoction
Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.
• Dapagliflozin
Dapagliflozin, 10mg at a time, once a day. Oral administration.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian medical university	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite endpoint incidence	The incidence of endpoint events:? eGFR decreased by 15% from baseline;? The incidence of doubling the quantitative change of 24-hour urinary protein (measured twice continuously).	Start of treatment until the end of the treatment for 12 weeks
Other	Incidence of adverse reactions	The proportion of patients with adverse reactions to the total population	Start of treatment until the end of the treatment for 12 weeks
Primary	Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline	Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.	12 weeks
Secondary	Change in 24-hour urine protein ration from baseline.	24-hour urinary protein quantification is being assessed once every 4 weeks for a total of 4 times during the whole study.	Start of treatment until the end of the treatment for 12 weeks