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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • National Taiwan University Hospital

    Taipei, Taiwan, 100

    Chun-Fu Lai, M.D., +886-2-23123456 ext. 63921, s821052@gmail.com

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT02304471
Study groupRoleWhat they receive
Controlhealthy subjects
CKDchronic kidney disease
ESRDend-stage renal disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted2 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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