Chronic Kidney DiseaseNCT03794401
Alternations of Intestinal Microbiota and Health Impact in CKD
An observational study of Chronic Kidney Disease, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 750 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 30 Jun 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Regional Hospital
Who may be able to join
- Patients with CKD stage 3-5 defined as eGFR <60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.
Who cannot join
- Patients with active cancer
- Patients with liver cirrhosis
- Patients have taken antibiotics within three months before screening for inclusion.
- Patients with a cardiac pacemaker or metallic implants,
- Patients are amputees
- Pregnant women
- Patients with inherited renal diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City
Szu-Chun Hung, MD
About this study
Official title: Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study
This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.
- Conditions
- Chronic Kidney Disease
- Keywords
- body composition, chronic kidney disease, dietary pattern, gut microbiot
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
renal outcome
a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
Measured: 3-year follow-up
cardiovascular outcome
a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
Measured: 3-year follow-up
Secondary outcomes (2)
all-cause mortality
CV death or non-CV death
Measured: 3-year follow-up
neurological outcome
the change of cognitive function or they development of dementia assessed by the Modified Mini-Mental Status Exam annually for 3 years
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- SZU-CHUNG HUNG, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794401
- Sponsor's protocol ID
- 07-XD-074
- Status last verified
- Feb 2022
- First submitted
- 1 Jan 2019
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternations of Intestinal Microbiota and Health Impact in Chronic Kidney Disease (AIM-HI CKD): A Cohort Study
- ClinicalTrials.gov ID
- NCT03794401
- Acronym / sponsor ID
- 07-XD-074
- Conditions
- Chronic Kidney Disease
- Keywords
- body composition, chronic kidney disease, dietary pattern, gut microbiot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Jan 2019 (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 study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Regional Hospital
Key inclusion criteria (1 listed)
- Patients with CKD stage 3-5 defined as eGFR <60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.
Key exclusion criteria (7 listed)
- Patients with active cancer
- Patients with liver cirrhosis
- Patients have taken antibiotics within three months before screening for inclusion.
- Patients with a cardiac pacemaker or metallic implants,
- Patients are amputees
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
renal outcome
Time frame: 3-year follow-up
a composite of ≥40% decrease in eGFR and ESRD needing chronic dialysis or preemptive kidney transplantation
cardiovascular outcome
Time frame: 3-year follow-up
a composite of major adverse CV events, defined as CV death, myocardial infarction, or ischemic stroke
2 secondary outcomes
all-cause mortality
Time frame: 3-year follow-up
neurological outcome
Time frame: 3-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
SZU-CHUNG HUNG principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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 Disease, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 1 inclusion and 7 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 2 Mar 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TING-YUN LIN (+886-2-66289779 ext. 2350, water_h2o_6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal outcome (time frame: 3-year follow-up). The study lists 2 primary outcomes in all. 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 2 Mar 2022.