Clinical trial NCT02885857: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin TongRenTang Group Co., Ltd.
First posted: 2016-09-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour urinary protein excretion
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Secondary outcomes:
measure: Serum creatinine
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Glomerular filtration rate
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Albumin
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Glycated hemoglobin
timeFrame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
measure: Symptom scores
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Other outcomes:
measure: Routine blood test
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Routine urine test
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Liver function
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Renal function tests
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Potassium detection
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: blood glucose testing
timeFrame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
measure: Electrocardiograph
timeFrame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
measure: chest radiography
timeFrame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
measure: Adverse events / adverse reactions
timeFrame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Locations:
city: Beijing
country: China
facility: National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital,Research Institute of Surgery Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou General Hospital Nanjing Military Command
state: Fujian
city: Xiamen
country: China
facility: 174th hospital of the People's Liberation Army
state: Fujian
city: Qinhuangdao
country: China
facility: Beidaihe Sanatorium of Beijing Military Mrca
state: Hebei
city: Harbin
country: China
facility: Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People'S Hospital
state: Henan
city: Jinan
country: China
facility: Shandong Province Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: LONGHUA Hospital Shanghai University of TCM
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
state: Tianjin
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: YongLi Zhan, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: HongTao Yang, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: 174th hospital of the People's Liberation Army
name: Meng Liang, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Beidaihe Sanatorium of Beijing Military Mrca
name: Lu Ma, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Heilongjiang University of Chinese Medicine
name: LiQun Song, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital of Central South University
name: QiaoLing Zhou, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Jilin University
name: Ping Luo, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi provincial peple's hospital
name: RongShan Li, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaanxi Traditional Chinese Medicine Hospital
name: XiaoHong Cheng, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Jie Wu, investigator
role: PRINCIPAL_INVESTIGATOR
References: