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

NCT05418465 | Unknown

• 1 other identifier: PJ-KS-KY-2021-228(X2)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathies

Keywords

Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in 24-hour urine protein ration from baseline.

  Start of treatment until the end of the treatment for 12 weeks

Other Outcomes (2)

• Composite endpoint incidence

  Start of treatment until the end of the treatment for 12 weeks

• Incidence of adverse reactions

  Start of treatment until the end of the treatment for 12 weeks

Study Arms (2)

Huangqi Guizhi Wuwu decoction group

EXPERIMENTAL

Huangqi Guizhi Wuwu decoction

Drug: Huangqi Guizhi Wuwu decoction

Dapagliflozin group

ACTIVE COMPARATOR

Dapagliflozin

Drug: Dapagliflozin

Interventions

Huangqi Guizhi Wuwu decoction DRUG

Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.

Huangqi Guizhi Wuwu decoction group

Dapagliflozin DRUG

Dapagliflozin, 10mg at a time, once a day. Oral administration.

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian medical university

Dalian, Liaoning, 116011, China

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: January 26, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

CN (1)