Chronic Kidney DiseasePhase 4NCT07741292
Niaoduqing Granules in Older Adults With Impaired Kidney Function
A Phase 4 study testing Intervention Name in people with Chronic Kidney Disease, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Intervention Name
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Nov 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 20040
Jing Chen, +86 021-52889000, chenjing1998@fudan.edu.cn
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Intervention Name
- Keywords
- Niaoduqing Granules, Older Adults, Non-Dialysis-Dependent Chronic Kidney Disease, Renal Function Decline, Frailty, Malnutrition
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention NameDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intervention Name |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 12 months from baseline through Month 60
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline through Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Dec 2025
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741292
- Sponsor's protocol ID
- KY2024-1366
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT07741292
- Acronym / sponsor ID
- KY2024-1366
- Conditions
- Chronic Kidney Disease
- Keywords
- Niaoduqing Granules, Older Adults, Non-Dialysis-Dependent Chronic Kidney Disease, Renal Function Decline, Frailty, Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Niaoduqing Granules | Experimental | Drug: Intervention NameParticipants 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. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention NameNiaoduqing 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. | Drug | Niaoduqing Granules |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention Name in people with Chronic Kidney Disease, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen, Professor and Chief Physician (+86 021-52889000, chenjing1998@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Rapid Kidney Function Decline (time frame: Every 12 months from baseline through Month 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.