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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Drug: Huangqi Guizhi Wuwu decoction; Drug: Dapagliflozin

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Recruiting
      • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Huangqi Guizhi Wuwu decoction group; Huangqi Guizhi Wuwu decoction	Drug: Huangqi Guizhi Wuwu decoction; Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.
ACTIVE_COMPARATOR: Dapagliflozin group; Dapagliflozin	Drug: Dapagliflozin; Dapagliflozin, 10mg at a time, once a day. Oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint incidence	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).	Start of treatment until the end of the treatment for 12 weeks
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (ACTUAL): June 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: PJ-KS-KY-2021-228(X2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No