Chronic Kidney DiseasesNCT03711617
Uremic Toxins and Outcomes in Chronic Kidney Disease
An observational study of Chronic Kidney Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The aim of this cohort study is: To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD patients from hospitals
Who may be able to join
- age ≥18 years old;
- clinically diagnosed with chronic kidney disease, according K/DOQI criteria.
Who cannot join
- acute kidney injury
- history of kidney injury <3 months
- malignancy
- pregnancy
- incomplete clinical data
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
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
Feng Ding, PhD, 86-21-53315165, dingfeng@sjtu.edu.cn
About this study
Official title: The Association Between Uremic Toxins and Outcomes and Comorbidities in Patients With CKD
The aim of this cohort study is:
To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.
Read the detailed description
To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, uremic toxin, prognosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CKD-ND | patients with non-dialysis CKD | |
| CKD-MHD | patients with maintenance hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 5 years
Secondary outcomes (1)
comorbidities
CVD,mortality,hospitalization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 May 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Feng Ding, PhD, Study chair, Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711617
- Sponsor's protocol ID
- CKD-toxins
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Uremic Toxins and Outcomes and Comorbidities in Patients With CKD
- ClinicalTrials.gov ID
- NCT03711617
- Acronym / sponsor ID
- CKD-toxins
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, uremic toxin, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Oct 2018 (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.
The aim of this cohort study is:
To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.
Detailed description
To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-ND | – | –patients with non-dialysis CKD |
| CKD-MHD | – | –patients with maintenance hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients from hospitals
Key inclusion criteria (2 listed)
- age ≥18 years old;
- clinically diagnosed with chronic kidney disease, according K/DOQI criteria.
Key exclusion criteria (5 listed)
- acute kidney injury
- history of kidney injury <3 months
- malignancy
- pregnancy
- incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: 5 years
1 secondary outcome
comorbidities
Time frame: 5 years
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 Dec 2024.
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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.
Feng Ding, PhD study chair
Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 2 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. 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.
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 Feng Ding, PhD (86-21-53315165, dingfeng@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 5 years). 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 Dec 2024.