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

Sponsor
The First Affiliated Hospital of Dalian Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05418465
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11.1
Anticipated Duration (Months)
9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. Composite endpoint incidence [Start of treatment until the end of the treatment for 12 weeks]

    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).

  2. Incidence of adverse reactions [Start of treatment until the end of the treatment for 12 weeks]

    The proportion of patients with adverse reactions to the total population

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Dalian medical university Dalian Liaoning China 116011

Sponsors and Collaborators

  • The First Affiliated Hospital of Dalian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ming Fang, Chief physician, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier:
NCT05418465
Other Study ID Numbers:
  • PJ-KS-KY-2021-228(X2)
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ming Fang, Chief physician, The First Affiliated Hospital of Dalian Medical University
Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Dapagliflozin

Study Results

No Results Posted as of Jun 14, 2022