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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Stage 3 Chronic Kidney Disease; Stage 4 Chronic Kidney Disease

Treatments: Drug: Fu-zheng-qu-zhuo (FZQZ) oral liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT02275468

SF-2009-Ⅲ-01

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

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.

Fu-zheng-qu-zhuo oral liquid Group

Experimental group

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.

Treatment:

Drug: Fu-zheng-qu-zhuo (FZQZ) oral liquid