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

Phase 2

Completed

• Conditions: Stage 3 Chronic Kidney Disease; Stage 4 Chronic Kidney Disease
• Interventions: Drug: Fu-zheng-qu-zhuo (FZQZ) oral liquid

• Registration Number: NCT02275468
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2013-05
• Status Verified: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-27
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fu-zheng-qu-zhuo oral liquid Group	Fu-zheng-qu-zhuo (FZQZ) oral liquid	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.

Primary Outcome Measures

Name	Time	Method
composite end point	12 month after the treatmnet and 3 years of the follow up time	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

Name	Time	Method
the slope of the eGFR versus observation time	12 month after the treatment	the decline of eGFR per-year

Trial Locations

Locations (3)

Guang anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Fangshan Hospital of Traditional Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Guang'an Men Hospital South; 🇨🇳 Beijing, China