Overview

Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis

Status:
Recruiting

Trial end date:
2023-03-15

Target enrollment:
0

Participant gender:
All

Summary

This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The First Affiliated Hospital of Dalian Medical University

Collaborators:

Huazhong University of Science and Technology
LinkDoc Technology (Beijing) Co. Ltd.

Treatments:

Valsartan

Criteria

Inclusion Criteria:

1. Diagnosed as primary glomerulonephritis by renal biopsy

2. Male or female, 18≤age≤65

3. Blood pressure can be effectively controlled at or below 140/90mmHg

4. 30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2）

5. 24-hour urine protein ration ≤ 2.0g/24h

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

Exclusion Criteria:

1. Diagnosed as secondary glomerulonephritis

2. Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or
ACEIs, without a two weeks washout period

3. Blood pressure < 90/60 mmHg

4. Serum potassium > 5.5 mmol/L

5. Serum albumin < 30g/L

6. Unilateral or bilateral renal artery stenosis

7. Pregnant or lactating women, and participants (including males) who were unable or
unwilling to take adequate contraception during the study period

8. Having comorbidities that affect the progression of primary glomerulonephritis
(including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver
cirrhosis, Diabetes, and Gout)

9. Allergic to the Huaiqihuang Granule or valsartan

10. Participating in another clinical trial

11. Investigators do not think it suitable for a participant to join this study