Chronic Kidney Disease
Conditions
Keywords
Niaoduqing Granules, Older Adults, Non-Dialysis-Dependent Chronic Kidney Disease, Renal Function Decline, Frailty, Malnutrition
Brief summary
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.
Interventions
DRUGIntervention Name
Niaoduqing Granules will be administered orally at a dose of 5 g three times daily at 6:00, 12:00, and 18:00 after meals with warm water for 12 months. Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions may be continued or adjusted according to specialist recommendations.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-group, open-label, real-world interventional study. All enrolled participants will receive Niaoduqing Granules at a dose of 5 g orally three times daily after meals for 12 months, in addition to their usual care. Participants will be followed for kidney function, nutritional status, frailty, cardiovascular and cerebrovascular events, mortality, gut microbiota, and blood metabolites. Participants with CKD stages 3, 4, and 5 will be evaluated as analytical subgroups and will not constitute separate intervention arms.
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Rapid Kidney Function Decline | Every 12 months from baseline through Month 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Chronic Kidney Disease Complications | Every 12 months from baseline through Month 60 | 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. |
| Occurrence of Malnutrition | At baseline and every 12 months through Month 60 | 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. |
| Occurrence of Frailty | At baseline and every 12 months through Month 60 | 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. |
| Occurrence of Cardiovascular and Cerebrovascular Events | From baseline through Month 60 | 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. |
| All-Cause Mortality | From baseline through Month 60 | The number and percentage of participants who die from any cause during the study follow-up period. |
Countries
China
Contacts
CONTACTJing Chen, Professor and Chief Physician
Outcome results
None listed