Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis

January 1, 2024 updated by: The First Affiliated Hospital of Dalian Medical University

Huaiqihuang Granule in CKD Stage 3 Primary Glomerulonephritis: A Multicentre Prospective, Randomized, Double-blind and Imitation, Positive-drug Parallel Controlled Clinical Trail

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dapeng Wang, MD
  • Phone Number: +86-18098875653
  • Email: bobowdp@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Hospital
        • Contact:
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou university second hospital
        • Contact:
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
        • Contact:
          • Yaling Bai, MD
          • Phone Number: +86-15081150811
          • Email: snbyl@163.com
      • Zhangjiakou, Hebei, China, 050000
        • Recruiting
        • The First Affiliated Hospital of Hebei North University
        • Contact:
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The 2nd Affiliated Hospital Of Harbin Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Recruiting
        • The first affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology
        • Contact:
        • Contact:
      • Chifeng, Inner Mongolia, China, 024000
        • Recruiting
        • Affiliated Hospital of Chifeng University
        • Contact:
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Recruiting
        • Changzhou No.2 People's Hospital
        • Contact:
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Province Hospital of Chinese Medicine
        • Contact:
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
        • Contact:
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
        • Contact:
    • Liaoning
      • Anshan, Liaoning, China, 114000
      • Anshan, Liaoning, China, 114000
        • Recruiting
        • Anshan Shuangshan Hospital
        • Contact:
        • Contact:
      • Anshan, Liaoning, China, 114000
        • Recruiting
        • Ansteel Group General Hospital
        • Contact:
        • Contact:
      • Benxi, Liaoning, China, 117000
        • Recruiting
        • Benxi Iron and Steel General Hospital of Liaoning Health Industry Group
        • Contact:
        • Contact:
      • Dalian, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Contact:
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • Dalian Ruikaier Nephropathy Hospital
        • Contact:
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shengjing Hospital of China Medical University( Huaxiang Area)
        • Contact:
        • Contact:
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
        • Contact:
      • Shenyang, Liaoning, China, 110010
        • Recruiting
        • Central Hospital Affiliated to Shenyang Medical College
        • Contact:
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University (Nanhu Area)
        • Contact:
          • Dajun Liu
      • Yingkou, Liaoning, China, 115000
        • Recruiting
        • Yingkou Central Hospital
        • Contact:
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Xiangdong Yang, MD
          • Phone Number: +86-18560083856
          • Email: yxd683@163.com
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • The Sixth People's Hospital affiliated to Shanghai Jiaotong University
        • Contact:
        • Contact:
          • Guihua Jian, MM
          • Phone Number: +86-18930173172
          • Email: gh238@qq.com
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
        • Contact:
      • Taiyuan, Shanxi, China, 300012
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • Kunming Yan'an Hospital
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Contact:
          • Maosheng Chen, MD
          • Phone Number: +86-15868103636
          • Email: cms213@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Huaiqihuang group
Combine the use of Huaiqihuang granules and Valsartan capsule simulant.
Drug: Huaiqihuang granules
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Other Names:
  • B12000050755
Active Comparator: Valsartan Group
Combine the use of Valsartan capsule and Huaiqihuang granules simulant.
Drug: Valsartan capsule
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
Other Names:
  • H20030638

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
Time Frame: 48 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinine levels from baseline
Time Frame: Start of treatment until the end of the treatment for 48 weeks
Serum creatinine is being assessed once every 8 weeks for a total of 6 times during the whole study
Start of treatment until the end of the treatment for 48 weeks
Change in 24-hour urine protein ration from baseline.
Time Frame: Start of treatment until the end of the treatment for 48 weeks
Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study
Start of treatment until the end of the treatment for 48 weeks
Changes in urine erythrocyte levels from baseline
Time Frame: Start of treatment until the end of the treatment for 48 weeks
Urine erythrocyte is being assessed once every 8 weeks for a total of 6 times during the whole study
Start of treatment until the end of the treatment for 48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint incidence
Time Frame: Start of treatment until the end of the treatment for 48 weeks
The incidence of endpoint events：① eGFR decreased by 15% from baseline and was reviewed within 2 weeks, if no improvement was found or if the eGFR continued to decrease by 15% below baseline；② Serum creatinine doubles or enters maintenance of renal replacement therapy or death
Start of treatment until the end of the treatment for 48 weeks
Incidence of adverse events
Time Frame: Start of treatment until the end of the treatment for 48 weeks
The proportion of patients with adverse events to the total population.
Start of treatment until the end of the treatment for 48 weeks
Incidence of adverse reactions
Time Frame: Start of treatment until the end of the treatment for 48 weeks
The proportion of patients with adverse reactions to the total population
Start of treatment until the end of the treatment for 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

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

Investigators

  • Principal Investigator: Hongli Lin, MD, The First Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HQH-201911

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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