Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Shenyan Kangfu Tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Beijing, Beijing, China, 100853
      • Recruiting
      • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
      • Contact: jie wu, doctor; Email: wujie301@163.com
      • Principal Investigator: xiangmei chen, doctor
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Daping Hospital,Research Institute of Surgery Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fuzhou General Hospital Nanjing Military Command
    • Xiamen, Fujian, China
      • Recruiting
      • 174th hospital of the People's Liberation Army
  • Hebei
    • Qinhuangdao, Hebei, China
      • Recruiting
      • Beidaihe Sanatorium of Beijing Military Mrca
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Heilongjiang University of Chinese Medicine
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Province Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital of Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • LONGHUA Hospital Shanghai University of TCM
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • First Hospital of Shanxi Medical University
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • First Teaching Hospital of Tianjin University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenyan kangfu Tablets; Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day	Drug: Shenyan Kangfu Tablet; Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24-hour urinary protein excretion	Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glomerular filtration rate		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Albumin		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glycated hemoglobin	Observations of the project value and the percentage change in value before and after the treatment.	Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Symptom scores		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine blood test		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Routine urine test		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Liver function		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Renal function tests		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Potassium detection		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
blood glucose testing		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Electrocardiograph		Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
chest radiography		Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Adverse events / adverse reactions	Follow-up 3 times.Subject at any time to contact your doctor.	Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times

Collaborators and Investigators

• Sponsor: Chen Xiangmei
• Collaborators: Tianjin TongRenTang Group Co., Ltd.
• Investigators: Principal Investigator: YongLi Zhan, investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Principal Investigator: HongTao Yang, investigator, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Principal Investigator: Meng Liang, investigator, 174th hospital of the People's Liberation Army; Principal Investigator: Lu Ma, investigator, Beidaihe Sanatorium of Beijing Military Mrca; Principal Investigator: LiQun Song, investigator, Heilongjiang University of Chinese Medicine; Principal Investigator: QiaoLing Zhou, investigator, Xiangya Hospital of Central South University; Principal Investigator: Ping Luo, investigator, Second Hospital of Jilin University; Principal Investigator: RongShan Li, investigator, Shanxi provincial peple's hospital; Principal Investigator: XiaoHong Cheng, investigator, Shaanxi Traditional Chinese Medicine Hospital; Principal Investigator: Jie Wu, investigator, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: S2015-023-02