Chronic Kidney DiseasePhase 4NCT02885857
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
A Phase 4 study testing Shenyan Kangfu Tablet in people with Chronic Kidney Disease, run by Chen Xiangmei at 13 sites in China.
Trial summary
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Shenyan Kangfu Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 13 sitesChina
- Study dates
- Jun 2015to Dec 2016
- 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
- Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- Aged from 18 to 70 years，male or female
- GFR≥45ml/min/1.73㎡
- 0.5g≤24 hours proteinuria≤3.0g
- glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
- Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
- Obtain the agreement of patients or their guardians, and signed informed consent file
Who cannot join
- Secondary nephropathy
- People allergic to Shenyankangfu tables
- Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
- Pregnant or lactating women
- Be participating in another clinical study at the same period
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
jie wu, doctor, wujie301@163.com
xiangmei chen, doctor
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
- Recruiting
Daping Hospital,Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality
- Recruiting
Fuzhou General Hospital Nanjing Military Command
Fuzhou, Fujian
- Recruiting
Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
- Recruiting
Shandong Province Hospital
Jinan, Shandong
- Recruiting
Beidaihe Sanatorium of Beijing Military Mrca
Qinhuangdao, Hebei
- Recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
- Recruiting
LONGHUA Hospital Shanghai University of TCM
Shanghai, Shanghai Municipality
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality
- Recruiting
174th hospital of the People's Liberation Army
Xiamen, Fujian
- Recruiting
Henan Provincial People'S Hospital
Zhengzhou, Henan
About this study
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Read the detailed description
Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.
Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.
- Conditions
- Chronic Kidney Disease
- Being tested
- Shenyan Kangfu Tablet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenyan Kangfu TabletDrug
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
| Study group | Role | What they receive |
|---|---|---|
| Shenyan kangfu Tablets | Experimental | Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day Receives: Drug: Shenyan Kangfu Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary protein excretion
Measured: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Secondary outcomes (5)
Serum creatinine
Measured: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glomerular filtration rate
Measured: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Albumin
Measured: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glycated hemoglobin
Observations of the project value and the percentage change in value before and after the treatment.
Measured: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Symptom scores
Measured: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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.
- 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
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xiangmei
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin TongRenTang Group Co., Ltd.
- Responsible party
- Sponsor-investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- YongLi Zhan, investigator, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical SciencesHongTao Yang, investigator, Principal investigator, First Teaching Hospital of Tianjin University of Traditional Chinese MedicineMeng Liang, investigator, Principal investigator, 174th hospital of the People's Liberation ArmyLu Ma, investigator, Principal investigator, Beidaihe Sanatorium of Beijing Military MrcaLiQun Song, investigator, Principal investigator, Heilongjiang University of Chinese MedicineQiaoLing Zhou, investigator, Principal investigator, Xiangya Hospital of Central South UniversityPing Luo, investigator, Principal investigator, Second Hospital of Jilin UniversityRongShan Li, investigator, Principal investigator, Shanxi provincial peple's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885857
- Sponsor's protocol ID
- S2015-023-02
- Status last verified
- Aug 2016
- First submitted
- 3 Jun 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02885857
- Acronym / sponsor ID
- S2015-023-02
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Chen XiangmeiUniversity, hospital or other
- Collaborators
- Tianjin TongRenTang Group Co., Ltd.
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Detailed description
Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.
Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shenyan kangfu Tablets | Experimental | Drug: Shenyan Kangfu TabletShenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- Aged from 18 to 70 years，male or female
- GFR≥45ml/min/1.73㎡
- 0.5g≤24 hours proteinuria≤3.0g
- glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
Key exclusion criteria (5 listed)
- Secondary nephropathy
- People allergic to Shenyankangfu tables
- Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
- Pregnant or lactating women
- Be participating in another clinical study at the same period
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 |
|---|---|---|
| Shenyan Kangfu TabletObservation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner. | Drug | Shenyan kangfu Tablets |
Primary outcome
24-hour urinary protein excretion
Time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
5 secondary outcomes
Serum creatinine
Time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glomerular filtration rate
Time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Albumin
Time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glycated hemoglobin
Time frame: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Symptom scores
Time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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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.
YongLi Zhan, investigator principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
HongTao Yang, investigator principal investigator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Meng Liang, investigator principal investigator
174th hospital of the People's Liberation Army
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenyan Kangfu Tablet in people with Chronic Kidney Disease, run by Chen Xiangmei at 13 sites 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 7 inclusion and 5 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Wu, chaieman (18210128683, wujie301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary protein excretion (time frame: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times). 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 1 Sep 2016.