Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4

Stage 3 Chronic Kidney Disease Clinical Trial

Official title:

Fu-zheng-qu-zhuo Oral Liquid Combined With Integrated Therapy Improves Renal Function in Patients of Chronic Kidney Disease Stage 3 and 4，a Randomized Placebo-Control Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275468
• Other study ID #: SF-2009-?-01
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2014
• Last updated: October 23, 2014
• Start date: June 2010
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

a prospective, multicenter (outpatient clinics of the three participating hospitals in Beijing), double blinded and randomized placebo-controlled study.

The study consisted of a 2-week run-in period and a 12-month treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

(1) Signed informed consent and aged from 18 to 75 years old. (2) Chronic renal diseases with Glomerular Filtration Rate (GFR) estimated using the CKD Epidemiology Collaboration (CKD-EPI) equation between 15 and 59 ml/min per 1.73 m2 on at least 2 dates separated by at least 90 days but no more than 6 month (the CKD defining window period). (3)Not received other TCM treatment for at least 2 weeks.

Exclusion Criteria:

(1) 50% increase in serum creatinine occurring within 2 month before screening. (2) Immediate need for dialysis. (3) Myocardial infarction or cerebrovascular accident in the 6 month preceding the trial. (4) Connective-tissue disease, obstructive uropathy and renal transplantation. (5) Patients with severe disease in other organs or cancer, psychotic diseases, and active tuberculosis. (6) Treatment with corticosteroid and immunosuppressive agents in recent 3 month. Hemoglobin (Hb) less than 80 g/L. (7) Diabetes Mellitus with uncontrolled Blood Sugar ( glycated hemoglobin (HbA1c) >8.0%). (8) Enrolled in other trials. (9) Women in pregnancy or lactation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic
• Stage 3 Chronic Kidney Disease
• Stage 4 Chronic Kidney Disease

Intervention

Drug:
• Fu-zheng-qu-zhuo (FZQZ) oral liquid
FZQZ oral liquid is a herbal medicine, composed of astragalus, angelica root, rhubarb, etc, with the effect of reinforcing Qi and activating blood, dissolving dampness and downbearing turbid.

Locations

Country	Name	City	State
China	Fangshan Hospital of Traditional Chinese Medicine	Beijing	Beijing
China	Guang anmen Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Guang'an Men Hospital South	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Fangshan Hospital of Traditional Chinese Medicine,, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite end point	end stage renal disease (defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min) and all cause of death	12 month after the treatmnet and 3 years of the follow up time	Yes
Secondary	the slope of the eGFR versus observation time	the decline of eGFR per-year	12 month after the treatment	Yes