Back to resultsHuangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathies
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Huangqi Guizhi Wuwu decoction
Dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed as diabetic nephropathy
- TCM syndrome differentiation is Qi deficiency and blood stasis type
- 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:
- Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
- Urinary tract infection (leukocytes in urinary sediment > 5 / HP)
- Serum potassium > 5.5 mmol/L
- Serum albumin < 30g/L
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)
- Participating in another clinical trial
- Investigators do not think it suitable for a participant to join this study
Sites / Locations
- The First Affiliated Hospital of Dalian medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Huangqi Guizhi Wuwu decoction group
Dapagliflozin group
Arm Description
Huangqi Guizhi Wuwu decoction
Dapagliflozin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05418465
First Posted
June 10, 2022
Last Updated
June 10, 2022
Sponsor
The First Affiliated Hospital of Dalian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05418465
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Huangqi Guizhi Wuwu decoction group
Arm Type
Experimental
Arm Description
Huangqi Guizhi Wuwu decoction
Arm Title
Dapagliflozin group
Arm Type
Active Comparator
Arm Description
Dapagliflozin
Intervention Type
Drug
Intervention Name(s)
Huangqi Guizhi Wuwu decoction
Intervention Description
Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin, 10mg at a time, once a day. Oral administration.
Primary Outcome Measure Information:
Title
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Description
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in 24-hour urine protein ration from baseline.
Description
24-hour urinary protein quantification is being assessed once every 4 weeks for a total of 4 times during the whole study.
Time Frame
Start of treatment until the end of the treatment for 12 weeks
Other Pre-specified Outcome Measures:
Title
Composite endpoint incidence
Description
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).
Time Frame
Start of treatment until the end of the treatment for 12 weeks
Title
Incidence of adverse reactions
Description
The proportion of patients with adverse reactions to the total population
Time Frame
Start of treatment until the end of the treatment for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed as diabetic nephropathy
TCM syndrome differentiation is Qi deficiency and blood stasis type
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:
Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
Urinary tract infection (leukocytes in urinary sediment > 5 / HP)
Serum potassium > 5.5 mmol/L
Serum albumin < 30g/L
Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)
Participating in another clinical trial
Investigators do not think it suitable for a participant to join this study
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian medical university
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dapeng Wang, MD
Phone
+86-18098875653
Email
bobowdp@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy
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