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

NCT02275468 | Completed Phase 2 DMC

• 1 other identifier: SF-2009-Ⅲ-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 3

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.

Conditions

Stage 3 Chronic Kidney Disease; Stage 4 Chronic Kidney Disease

Keywords

Chronic Kidney Disease; eGFR slope; Herbal medicine Fu-zheng-qu-zhuo Oral liquid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the slope of the eGFR versus observation time

  12 month after the treatment

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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.

Fu-zheng-qu-zhuo oral liquid Group

EXPERIMENTAL

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

Interventions

Fu-zheng-qu-zhuo (FZQZ) oral liquid DRUG

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.

Also known as: FZQZ oral liquid

Fu-zheng-qu-zhuo oral liquid Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Fangshan Hospital of Traditional Chinese Medicine,: collaborator
• Peking University First Hospital: collaborator

Study Sites (3)

Guang anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Fangshan Hospital of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Location

Guang'an Men Hospital South

Beijing, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

fu-zheng-qu-zhuo; Fluid Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jie Wang

  Guang anmen Hospital, China Academy of Chinese Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

CN (3)