Niaoduqing Granules in Older Adults With Impaired Kidney Function

Phase 4RecruitingNCT07741292

Huashan Hospital300 enrolled

Overview

This prospective real-world study will evaluate the clinical benefits of Niaoduqing Granules in older adults with impaired kidney function. Approximately 300 participants aged over 60 years with stage 3 to 5 chronic kidney disease who are not receiving dialysis will be enrolled at Huashan Hospital, Fudan University. The study will examine whether treatment with Niaoduqing Granules is associated with slower kidney function decline and improvements in nutrition, frailty, and other health outcomes. Participants will receive 5 g of Niaoduqing Granules three times daily after meals for 12 months, while continuing their usual treatment for chronic diseases as directed by their physicians. Kidney function, laboratory results, nutritional status, frailty, cardiovascular and cerebrovascular events, and survival will be assessed during follow-up. Blood, urine, and stool samples will also be collected to study changes in gut microorganisms and blood metabolites that may help explain how Niaoduqing Granules affect health. Participants will be followed for up to 60 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Chronic Kidney Disease

Interventions

Eligibility

Sex: ALLMin age: 61 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis. 2. Age older than 60 years. 3. The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations. 4. The underlying cause of chronic kidney disease is clinically stable. Exclusion Criteria: 1. Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease. 2. Active infection, defined as C-reactive protein greater than 10 mg/L, or current use of nephrotoxic medications. 3. Limb paralysis or major limb impairment. 4. Use of immunosuppressive therapy, including cyclosporine or tacrolimus, within the 3 months before cohort enrollment, or use of corticosteroids at a dose equivalent to more than 10 mg/day of prednisone. 5. Severe gastrointestinal disease affecting nutrient absorption. 6. Current participation in, or participation within the previous month in, another study related to diet or medication. 7. Known allergy to Niaoduqing Granules. 8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Outcomes

Primary Outcomes

Occurrence of Rapid Kidney Function Decline

Rapid kidney function decline is defined as an annual decrease in estimated glomerular filtration rate (eGFR) of more than 5%. The occurrence of rapid kidney function decline will be determined using serial kidney function measurements obtained during follow-up.

Time frame: Every 12 months from baseline through Month 60

Secondary Outcomes

Incidence of Chronic Kidney Disease Complications

The number and percentage of participants who develop chronic kidney disease complications, including renal anemia and/or chronic kidney disease-mineral and bone disorder (CKD-MBD), during follow-up. Outcomes will be assessed using clinical evaluations and relevant laboratory test results collected according to the study protocol.

Time frame: Every 12 months from baseline through Month 60

Occurrence of Malnutrition

Malnutrition will be assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. A participant will be classified as having malnutrition when at least one phenotypic criterion, including involuntary weight loss, low body mass index, or reduced muscle mass, and at least one etiologic criterion, including reduced food intake or absorption or disease burden/inflammation, are present.

Time frame: At baseline and every 12 months through Month 60

Occurrence of Frailty

Frailty status will be assessed using a rapid geriatric frailty screening scale. The number and percentage of participants identified as having frailty according to the screening assessment will be recorded.

Time frame: At baseline and every 12 months through Month 60

Occurrence of Cardiovascular and Cerebrovascular Events

The number and percentage of participants who experience one or more cardiovascular or cerebrovascular events during follow-up. Events include acute myocardial infarction, unstable angina, coronary heart disease, acute heart failure or worsening chronic heart failure, new-onset arrhythmia, acute cerebral infarction, transient ischemic attack, intracerebral hemorrhage, peripheral vascular disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, valvular heart disease, or aortic disease.

Time frame: From baseline through Month 60

All-Cause Mortality

The number and percentage of participants who die from any cause during the study follow-up period.