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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage 4 Chronic Kidney Disease; Stage 3 Chronic Kidney Disease
• Intervention / Treatment: Drug: Fu-zheng-qu-zhuo (FZQZ) oral liquid

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Guang'an Men Hospital South
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang anmen Hospital, China Academy of Chinese Medical Sciences
    • Beijing, Beijing, China
      • Fangshan Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Patients of Control Group received FZQZ-Placebo 20ml every time, and three times a day combined with integrated therapy.The integrated therapy was as follows: (1)low-protein dietary with sufficient calorie supply.(2) Anti-hypertensive agents to achieve a systolic blood pressure of less than 140 mm Hg and a diastolic blood pressure of less than 90 mmHg.(3)Anti-hyperlipidemic agentsas necessary to achieve low-density lipoprotein cholesterol（LDL-CH）less than 2.6mmol/L and triglycerides less than1.7mmol/L.（4）Patients with Diabetes Mellitus received insulin or oral hypoglycemic agents to achieve HbA1c 6.5～8.0%. (5)Received Sodium Bicarbonate as necessary to achieve serum HCO3-≥22mmol/L.(6) Received ferrous succinate, folic acid, and erythropoietin to achieve HB 90~110g/L.
Experimental: Fu-zheng-qu-zhuo oral liquid Group; Patients of FZQZ Group received Fu-zheng-qu-zhuo (FZQZ) oral liquid 20ml every time, and three times a day combined with integrated therapy. The integrated therapy was same to Control Group.	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.; Other Names: FZQZ oral liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the slope of the eGFR versus observation time	the decline of eGFR per-year	12 month after the treatment

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Peking University First Hospital; Fangshan Hospital of Traditional Chinese Medicine,
• Investigators: Study Chair: Jie Wang, Guang anmen Hospital, China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 23, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; eGFR slope; Herbal medicine Fu-zheng-qu-zhuo Oral liquid
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SF-2009-Ⅲ-01