Chronic Kidney Disease Stage 3BPhase 4NCT04349683
Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis
A Phase 4 study testing Jinshuibao in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Jemincare.
Trial summary
This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Glomerulonephritis
- What is being tested?
- Jinshuibao
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2020to 30 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >= 18 years old and <= 70 years old.
- Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
- Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard).
- 24-hour urinary protein < 3g during the screening period.
- Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L.
- Patients who have signed the informed consent.
Who cannot join
- Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
- Allergy to Jinshuibao.
- Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
- Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months.
- History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery.
- History of organ transplant, including kidney transplant.
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- History of severe diseases of the heart, brain, liver, hematopoietic system or other serious diseases affecting survival, such as malignant tumors, myocardial infarction, unstable angina, stroke or transient ischemic attack in recent 6 months.
- Patients whose disease progresses too rapidly judged by the clinician.
- Enrolled in other trials in recent 3 months.
- Patients who are assessed by investigator as unsuitable for inclusion.
About this study
Official title: Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial
This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.
Read the detailed description
Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.
- Being tested
- Jinshuibao, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JinshuibaoDrug
Also called basic treatment
6 capsules at a time, 3 times a day (tid).
PlaceboDrug
Also called basic treatment
6 capsules at a time, 3 times a day (tid).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | basic treatment combined with Jinshuibao Receives: Drug: Jinshuibao |
| Control group | Placebo comparator | basic treatment and placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of estimated glomerular filtration rate
Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation
Measured: Baseline to 48 weeks
Secondary outcomes (7)
Change of surem creatinine and 24-hour urine protein
Surem creatinine (Scr) will be tested by a central laboratory
Measured: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of urinary protein/creatinine ratio (PCR)
Change from baseline in PCR
Measured: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of hs-CRP
Change from baseline in hs-CRP
Measured: Baseline to 24 weeks, 48 weeks
Change of TNF-α, IL-1β, and IL-6
Change from baseline in TNF-α, IL-1β, and IL-6
Measured: Baseline to 24 weeks and 48 weeks
Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD
End stage renal disease (ESRD）is defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min
Measured: 48 weeks
Patients' Quality of life
Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version)
Measured: Baseline to 24 weeks and 48 weeks
Number of rehospitalizations
Number of rehospitalizations during the follow-up period
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 3BStudies of the same condition, open and under way.
- More trials run by JemincareThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349683
- Sponsor's protocol ID
- NE-JSB-01
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04349683
- Acronym / sponsor ID
- NE-JSB-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 16 Apr 2020 (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 is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.
Detailed description
Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Jinshuibaobasic treatment combined with Jinshuibao |
| Control group | Placebo comparator | Drug: Placebobasic treatment and placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged >= 18 years old and <= 70 years old.
- Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
- Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard).
- 24-hour urinary protein < 3g during the screening period.
- Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L.
Key exclusion criteria (10 listed)
- Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
- Allergy to Jinshuibao.
- Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
- Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months.
- History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery.
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 |
|---|---|---|
| JinshuibaoAlso: basic treatment6 capsules at a time, 3 times a day (tid). | Drug | Experimental group |
| PlaceboAlso: basic treatment6 capsules at a time, 3 times a day (tid). | Drug | Control group |
Primary outcome
Change of estimated glomerular filtration rate
Time frame: Baseline to 48 weeks
Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation
7 secondary outcomes
Change of surem creatinine and 24-hour urine protein
Time frame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of urinary protein/creatinine ratio (PCR)
Time frame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of hs-CRP
Time frame: Baseline to 24 weeks, 48 weeks
Change of TNF-α, IL-1β, and IL-6
Time frame: Baseline to 24 weeks and 48 weeks
Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD
Time frame: 48 weeks
Patients' Quality of life
Time frame: Baseline to 24 weeks and 48 weeks
Number of rehospitalizations
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jinshuibao in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Jemincare.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of estimated glomerular filtration rate (time frame: Baseline to 48 weeks). 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 20 Apr 2020.