Chronic Kidney DiseaseNCT02304471
Circulating lncRNA and CV Morbidities in CKD and ESRD
An observational study of Chronic Kidney Disease and End-stage Renal Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, End-stage Renal Disease
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2014to Dec 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD, ESRD, Healthy controls
Who may be able to join
- 1.Adult patients with various stages 1-5 of CKD will be enrolled at outpatient clinic. Definition and staging of CKD were defined by estimated glomerular filtration rate by the Modification of Diet in Renal Disease study equation.
- 2.Patients with ESRD under maintenance hemodialysis or peritoneal dialysis will also be included.
Who cannot join
- 1.age younger than 20 years or older than 80 years.
- 2.pregnant woman.
- 3.patients already received kidney transplantation.
- 4.recent hospitalization within previous one month.
- 5.for ESRD patients, receiving maintenance hemodialysis or peritoneal dialysis for less than 3 months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Chun-Fu Lai, M.D., +886-2-23123456 ext. 63921, s821052@gmail.com
About this study
Official title: Circulating Long Non-coding RNAs and Cardiovascular Morbidities in Chronic Kidney Disease and End-Stage Renal Disease
Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive.
Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer than 200 nucleotides. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cardiovascular complications in patients with renal dysfunction.
In this proposal, the investigators seek to apply next-generation sequencing technology to investigate circulating lncRNA expression in control subjects and in patients with CKD and ESRD. The investigators will test the hypothesis that circulating lncRNA expression signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene co-expression network analysis will be conducted to identify lncRNAs that are functionally involved in the pathogenesis of CKD and ESRD. Next, the investigators will identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients. Finally, the investigators propose to test the hypothesis that circulating lncRNAs can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression in CKD patients. The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to uremic cardiovascular complications and renal function progression.
Read the detailed description
Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Patients with CKD and ESRD are at high risk for myocardial dysfunction, ischemia and heart failure. The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive. In addition, conventional therapeutics proven effective in reducing cardiovascular events in general population fail to provide similar benefits in uremic patients. There is a clear need to identify novel mediators of cardiovascular complications in uremic patients to provide insights into the pathogenesis, to tailor clinical care based on cardiovascular risks, and to develop new therapeutic strategies.
It has become increasingly clear that the transcription of the eukaryotic genome is far more pervasive and complex than previously appreciated. While the expression of messenger RNAs (mRNAs) and microRNAs (miRNAs) account for only ~1% of all transcribed species, up to 90% of the mammalian genome is transcribed as long non-coding RNAs (lncRNAs), a heterogeneous group of non-coding transcripts longer than 200 nucleotides. LncRNAs have been shown to be functional and involved in specific physiological and pathological processes through epigenetic, transcriptional and post-transcriptional mechanisms. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cardiovascular complications in patients with renal dysfunction.
In this proposal, we seek to apply next-generation sequencing technology to investigate circulating (plasma and peripheral blood mononuclear cells [PBMC]) lncRNA expression in control subjects and in patients with CKD and ESRD. We will test the hypothesis that circulating lncRNA expression signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene co-expression network analysis will be conducted to identify lncRNAs that are functionally involved in the pathogenesis of CKD and ESRD. Next, we will identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients. The hypothesis that circulating lncRNAs can be used to predict the progression of myocardial dysfunction, the occurrence of adverse cardiovascular events and death among patients with ESRD, will be tested. The sensitivity and specificity of using circulating lncRNAs to predict cardiovascular function/outcomes in ESRD patients will be tested prospectively in an independent ESRD population. Finally, we propose to test the hypothesis that circulating lncRNAs can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression in CKD patients. The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to uremic cardiovascular complications and renal function progression. These experiments will also help to design better diagnostic and prognostic tools in CKD/ESRD patients, as well as to develop novel therapeutic strategies to treat or prevent CKD progression and uremic cardiovascular complications.
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, 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 |
|---|---|---|
| Control | healthy subjects | |
| CKD | chronic kidney disease | |
| ESRD | end-stage renal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse cardiovascular events (acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death)
Adverse cardiovascular events including acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death will be recorded over the follow-up period.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2018 (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 National Taiwan University 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Fu Lai, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304471
- Sponsor's protocol ID
- 201409019RINB
- Status last verified
- Nov 2014
- First submitted
- 26 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Long Non-coding RNAs and Cardiovascular Morbidities in Chronic Kidney Disease and End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02304471
- Acronym / sponsor ID
- 201409019RINB
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Dec 2014 (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.
Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive.
Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer than 200 nucleotides. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cardiovascular complications in patients with renal dysfunction.
In this proposal, the investigators seek to apply next-generation sequencing technology to investigate circulating lncRNA expression in control subjects and in patients with CKD and ESRD. The investigators will test the hypothesis that circulating lncRNA expression signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene co-expression network analysis will be conducted to identify lncRNAs that are functionally involved in the pathogenesis of CKD and ESRD. Next, the investigators will identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients. Finally, the investigators propose to test the hypothesis that circulating lncRNAs can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression in CKD patients. The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to uremic cardiovascular complications and renal function progression.
Detailed description
Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Patients with CKD and ESRD are at high risk for myocardial dysfunction, ischemia and heart failure. The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive. In addition, conventional therapeutics proven effective in reducing cardiovascular events in general population fail to provide similar benefits in uremic patients. There is a clear need to identify novel mediators of cardiovascular complications in uremic patients to provide insights into the pathogenesis, to tailor clinical care based on cardiovascular risks, and to develop new therapeutic strategies.
It has become increasingly clear that the transcription of the eukaryotic genome is far more pervasive and complex than previously appreciated. While the expression of messenger RNAs (mRNAs) and microRNAs (miRNAs) account for only ~1% of all transcribed species, up to 90% of the mammalian genome is transcribed as long non-coding RNAs (lncRNAs), a heterogeneous group of non-coding transcripts longer than 200 nucleotides. LncRNAs have been shown to be functional and involved in specific physiological and pathological processes through epigenetic, transcriptional and post-transcriptional mechanisms. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cardiovascular complications in patients with renal dysfunction.
In this proposal, we seek to apply next-generation sequencing technology to investigate circulating (plasma and peripheral blood mononuclear cells [PBMC]) lncRNA expression in control subjects and in patients with CKD and ESRD. We will test the hypothesis that circulating lncRNA expression signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene co-expression network analysis will be conducted to identify lncRNAs that are functionally involved in the pathogenesis of CKD and ESRD. Next, we will identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients. The hypothesis that circulating lncRNAs can be used to predict the progression of myocardial dysfunction, the occurrence of adverse cardiovascular events and death among patients with ESRD, will be tested. The sensitivity and specificity of using circulating lncRNAs to predict cardiovascular function/outcomes in ESRD patients will be tested prospectively in an independent ESRD population. Finally, we propose to test the hypothesis that circulating lncRNAs can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression in CKD patients. The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to uremic cardiovascular complications and renal function progression. These experiments will also help to design better diagnostic and prognostic tools in CKD/ESRD patients, as well as to develop novel therapeutic strategies to treat or prevent CKD progression and uremic cardiovascular complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –healthy subjects |
| CKD | – | –chronic kidney disease |
| ESRD | – | –end-stage renal disease |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD, ESRD, Healthy controls
Key inclusion criteria (2 listed)
- 1.Adult patients with various stages 1-5 of CKD will be enrolled at outpatient clinic. Definition and staging of CKD were defined by estimated glomerular filtration rate by the Modification of Diet in Renal Disease study equation.
- 2.Patients with ESRD under maintenance hemodialysis or peritoneal dialysis will also be included.
Key exclusion criteria (5 listed)
- 1.age younger than 20 years or older than 80 years.
- 2.pregnant woman.
- 3.patients already received kidney transplantation.
- 4.recent hospitalization within previous one month.
- 5.for ESRD patients, receiving maintenance hemodialysis or peritoneal dialysis for less than 3 months.
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
Adverse cardiovascular events (acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death)
Time frame: 3 years
Adverse cardiovascular events including acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death will be recorded over the follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Chun-Fu Lai, M.D. principal investigator
National Taiwan University Hospital
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 and End-stage Renal Disease, run by National Taiwan University Hospital 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 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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 Chun-Fu Lai, M.D. (+886-2-23123456 ext. 63921, s821052@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse cardiovascular events (acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death) (time frame: 3 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 2 Dec 2014.