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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shenyan Kangfu Tablet
Sponsored by
Chen Xiangmei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;
  2. Aged from 18 to 70 years，male or female
  3. GFR≥45ml/min/1.73㎡
  4. 0.5g≤24 hours proteinuria≤3.0g
  5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
  6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  7. Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  1. Secondary nephropathy
  2. People allergic to Shenyankangfu tables
  3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  4. Pregnant or lactating women
  5. Be participating in another clinical study at the same period

Sites / Locations

  • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General HospitalRecruiting
  • Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
  • Daping Hospital,Research Institute of Surgery Third Military Medical UniversityRecruiting
  • Fuzhou General Hospital Nanjing Military CommandRecruiting
  • 174th hospital of the People's Liberation ArmyRecruiting
  • Beidaihe Sanatorium of Beijing Military MrcaRecruiting
  • Heilongjiang University of Chinese MedicineRecruiting
  • Henan Provincial People'S HospitalRecruiting
  • Shandong Province HospitalRecruiting
  • Changhai Hospital of ShanghaiRecruiting
  • LONGHUA Hospital Shanghai University of TCMRecruiting
  • First Hospital of Shanxi Medical UniversityRecruiting
  • First Teaching Hospital of Tianjin University of TCMRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shenyan kangfu Tablets

Arm Description

Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day

Outcomes

Primary Outcome Measures

24-hour urinary protein excretion

Secondary Outcome Measures

Serum creatinine
Glomerular filtration rate
Albumin
Glycated hemoglobin
Observations of the project value and the percentage change in value before and after the treatment.
Symptom scores

Full Information

First Posted
June 3, 2015
Last Updated
August 26, 2016
Sponsor
Chen Xiangmei
Collaborators
Tianjin TongRenTang Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02885857
Brief Title
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
Official Title
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Xiangmei
Collaborators
Tianjin TongRenTang Group Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Detailed Description
Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease. The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients. Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shenyan kangfu Tablets
Arm Type
Experimental
Arm Description
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
Intervention Type
Drug
Intervention Name(s)
Shenyan Kangfu Tablet
Intervention Description
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
Primary Outcome Measure Information:
Title
24-hour urinary protein excretion
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Secondary Outcome Measure Information:
Title
Serum creatinine
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Glomerular filtration rate
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Albumin
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Glycated hemoglobin
Description
Observations of the project value and the percentage change in value before and after the treatment.
Time Frame
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Title
Symptom scores
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Other Pre-specified Outcome Measures:
Title
Routine blood test
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Routine urine test
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Liver function
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Renal function tests
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Potassium detection
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
blood glucose testing
Time Frame
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Title
Electrocardiograph
Time Frame
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Title
chest radiography
Time Frame
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Title
Adverse events / adverse reactions
Description
Follow-up 3 times.Subject at any time to contact your doctor.
Time Frame
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with primary glomerulonephritis or diabetic nephropathy; Aged from 18 to 70 years，male or female GFR≥45ml/min/1.73㎡ 0.5g≤24 hours proteinuria≤3.0g glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy) Traditional Chinese medicine syndrome conform Qi-Yin Deficiency Obtain the agreement of patients or their guardians, and signed informed consent file Exclusion Criteria: Secondary nephropathy People allergic to Shenyankangfu tables Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life Pregnant or lactating women Be participating in another clinical study at the same period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Wu, chaieman
Phone
18210128683
Email
wujie301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
SiJi Li, director
Phone
13821669488
Email
miaoshujie@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YongLi Zhan, investigator
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HongTao Yang, investigator
Organizational Affiliation
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meng Liang, investigator
Organizational Affiliation
174th hospital of the People's Liberation Army
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lu Ma, investigator
Organizational Affiliation
Beidaihe Sanatorium of Beijing Military Mrca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LiQun Song, investigator
Organizational Affiliation
Heilongjiang University of Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
QiaoLing Zhou, investigator
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Luo, investigator
Organizational Affiliation
Second Hospital of Jilin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
RongShan Li, investigator
Organizational Affiliation
Shanxi provincial peple's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
XiaoHong Cheng, investigator
Organizational Affiliation
Shaanxi Traditional Chinese Medicine Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Wu, investigator
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jie wu, doctor
Email
wujie301@163.com
First Name & Middle Initial & Last Name & Degree
xiangmei chen, doctor
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Daping Hospital,Research Institute of Surgery Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
Fuzhou General Hospital Nanjing Military Command
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
174th hospital of the People's Liberation Army
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Beidaihe Sanatorium of Beijing Military Mrca
City
Qinhuangdao
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People'S Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Province Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
LONGHUA Hospital Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Name
First Teaching Hospital of Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

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