A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Huashan Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Occurrence of Rapid Kidney Function Decline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 61 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis.
- •Age older than 60 years.
- •The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations.
- •The underlying cause of chronic kidney disease is clinically stable.
Exclusion Criteria
- •Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease.
- •Active infection, defined as C-reactive protein greater than 10 mg/L, or current use of nephrotoxic medications.
- •Limb paralysis or major limb impairment.
- •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.
- •Severe gastrointestinal disease affecting nutrient absorption.
- •Current participation in, or participation within the previous month in, another study related to diet or medication.
- •Known allergy to Niaoduqing Granules.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Outcomes
Primary Outcomes
Occurrence of Rapid Kidney Function Decline
Time Frame: 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 Outcomes
- Incidence of Chronic Kidney Disease Complications(Every 12 months from baseline through Month 60)
- Occurrence of Malnutrition(At baseline and every 12 months through Month 60)
- Occurrence of Frailty(At baseline and every 12 months through Month 60)
- Occurrence of Cardiovascular and Cerebrovascular Events(From baseline through Month 60)
- All-Cause Mortality(From baseline through Month 60)
Investigators
Chen Jing
Professor
Huashan Hospital