Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02885857
• Other study ID #: S2015-023-02
• Status: Recruiting
• Phase: Phase 4
• First received: June 3, 2015
• Last updated: August 26, 2016
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Chinese PLA General Hospital
• Contact: Jie Wu, chaieman
• Phone: 18210128683
• Email: wujie301[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital	Beijing	Beijing
China	Daping Hospital,Research Institute of Surgery Third Military Medical University	Chongqing	Chongqing
China	Fuzhou General Hospital Nanjing Military Command	Fuzhou	Fujian
China	Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	Shandong Province Hospital	Jinan	Shandong
China	Beidaihe Sanatorium of Beijing Military Mrca	Qinhuangdao	Hebei
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	LONGHUA Hospital Shanghai University of TCM	Shanghai	Shanghai
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	First Teaching Hospital of Tianjin University of TCM	Tianjin	Tianjin
China	174th hospital of the People's Liberation Army	Xiamen	Fujian
China	Henan Provincial People'S Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Chen Xiangmei	Tianjin TongRenTang Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Routine blood test		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	Routine urine test		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	Liver function		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	Renal function tests		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	Potassium detection		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	blood glucose testing		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Other	Electrocardiograph		Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times	No
Other	chest radiography		Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times	No
Other	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	No
Primary	24-hour urinary protein excretion		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Secondary	Serum creatinine		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Secondary	Glomerular filtration rate		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Secondary	Albumin		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No
Secondary	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	No
Secondary	Symptom scores		Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times	No