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

Primary Purpose

Stage 3 Chronic Kidney Disease, Stage 4 Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fu-zheng-qu-zhuo (FZQZ) oral liquid
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage 3 Chronic Kidney Disease focused on measuring Chronic Kidney Disease, eGFR slope, Herbal medicine Fu-zheng-qu-zhuo Oral liquid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Fu-zheng-qu-zhuo oral liquid Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the slope of the eGFR versus observation time
the decline of eGFR per-year

Full Information

First Posted
October 23, 2014
Last Updated
October 23, 2014
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Fangshan Hospital of Traditional Chinese Medicine,, Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02275468
Brief Title
Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Fangshan Hospital of Traditional Chinese Medicine,, Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 3 Chronic Kidney Disease, Stage 4 Chronic Kidney Disease
Keywords
Chronic Kidney Disease, eGFR slope, Herbal medicine Fu-zheng-qu-zhuo Oral liquid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Fu-zheng-qu-zhuo oral liquid Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fu-zheng-qu-zhuo (FZQZ) oral liquid
Other Intervention Name(s)
FZQZ oral liquid
Intervention Description
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.
Primary Outcome Measure Information:
Title
composite end point
Description
end stage renal disease (defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min) and all cause of death
Time Frame
12 month after the treatmnet and 3 years of the follow up time
Secondary Outcome Measure Information:
Title
the slope of the eGFR versus observation time
Description
the decline of eGFR per-year
Time Frame
12 month after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Wang
Organizational Affiliation
Guang anmen Hospital, China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Guang anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Fangshan Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guang'an Men Hospital South
City
Beijing
Country
China

12. IPD Sharing Statement

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

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