Niaoduqing Granules in Older Adults With Impaired Kidney Function

A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function

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 Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Intervention Name

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jing Chen, Professor and Chief Physician; Phone Number: +86 021-52889000; Email: chenjing1998@fudan.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 20040
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Jing Chen; Phone Number: +86 021-52889000; Email: chenjing1998@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Niaoduqing Granules; Participants will receive Niaoduqing Granules 5 g orally three times daily at 6:00, 12:00, and 18:00 after meals for 12 months. Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions will be continued or adjusted according to specialist recommendations.	Drug: Intervention 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every 12 months from baseline through Month 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From baseline through Month 60

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Malnutrition; Frailty; Renal Function Decline; Niaoduqing Granules; Non-Dialysis-Dependent Chronic Kidney Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Frailty; Malnutrition; Renal Insufficiency, Chronic
• Other Study ID Numbers: KY2024-1366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No