Niaoduqing Granules in Older Adults With Impaired Kidney Function

NCT07741292 | Recruiting Phase 4 DMC

• 1 other identifier: KY2024-1366
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Niaoduqing Granules; Older Adults; Non-Dialysis-Dependent Chronic Kidney Disease; Renal Function Decline; Frailty; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Niaoduqing Granules

EXPERIMENTAL

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

Interventions

Intervention Name DRUG

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.

Niaoduqing Granules

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 20040, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty; Malnutrition

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Jing Chen, Professor and Chief Physician

CONTACT

+86 021-52889000; chenjing1998@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)