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NCT Number: NCT07741292

Niaoduqing Granules in Older Adults With Impaired Kidney 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.

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Key information

Conditions

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

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 20040, China

Location status: Recruiting

Location contact

Jing Chen

CONTACT

[email protected]

+86 021-52889000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Incidence of Chronic Kidney Disease Complications

    Time frame: 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.

  2. Occurrence of Malnutrition

    Time frame: 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.

  3. Occurrence of Frailty

    Time frame: 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.

  4. Occurrence of Cardiovascular and Cerebrovascular Events

    Time frame: 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.

  5. All-Cause Mortality

    Time frame: From baseline through Month 60

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Chen, Professor and Chief Physician

CONTACT

[email protected]

+86 021-52889000

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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