Niaoduqing Granules in Older Adults With Impaired Kidney Function

Official title

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

Overview

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

• 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.

Primary outcome measures

• Occurrence of Rapid Kidney Function Decline [Time frame: Every 12 months from baseline through Month 60]

Secondary outcome measures (5)

• Incidence of Chronic Kidney Disease Complications [Time frame: Every 12 months from baseline through Month 60]
• Occurrence of Malnutrition [Time frame: At baseline and every 12 months through Month 60]
• Occurrence of Frailty [Time frame: At baseline and every 12 months through Month 60]
• Occurrence of Cardiovascular and Cerebrovascular Events [Time frame: From baseline through Month 60]
• All-Cause Mortality [Time frame: From baseline through Month 60]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07741292 · KY2024-1366

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗