Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3

July 10, 2024 updated by: The First Affiliated Hospital of Dalian Medical University

Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
466

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
    • Ningxia Hui Autonomous Region
      • Yinchuan, Ningxia Hui Autonomous Region, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Dalian Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Huazhong University of Science and Technology
LinkDoc Technology (Beijing) Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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