Gastroesophageal Reflux DiseaseNCT01634672
Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients
An observational study of Gastroesophageal Reflux Disease, run by Song Kyung Ho at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Oct 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with chronic kidney disease undergoing peritoneal dialysis and hemodialysis over 1 year were enrolled
Who may be able to join
- peritoneal dialysis and hemodialysis patients
Who cannot join
- a history of abdominal surgery or with a proton pump inhibitor before 1 month and a eradication of H. pylori were excluded
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.
Read the detailed description
Gastroesophageal reflux disease is a common upper gastrointestinal disorder in chronic kidney disease. But, little is known about the prevalence in dialysis patients. The aims of this study were to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, peritoneal dialysis, hemodialysis
- Medical subject headings
- Gastroesophageal Reflux
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 |
|---|---|---|
| hemodialysis patients | Not described | |
| Peritoneal dialysis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis
Measured: 2 yrs
Secondary outcomes (1)
risk factor for GERD in peritoneal dialysis and hemodialysis patients
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Song Kyung Ho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Song Kyung Ho, Konyang University Hospital
- Investigators
- Hyun jung Song, Bechelor's, Principal investigator, Konyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634672
- Sponsor's protocol ID
- GERD
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gastroesophageal Reflux Disease in Peritoneal Dialysis and Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01634672
- Acronym / sponsor ID
- GERD
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, peritoneal dialysis, hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Song Kyung HoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 6 Jul 2012 (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.
The purpose of this study is to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.
Detailed description
Gastroesophageal reflux disease is a common upper gastrointestinal disorder in chronic kidney disease. But, little is known about the prevalence in dialysis patients. The aims of this study were to determine the prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis patients | – | – |
| Peritoneal dialysis patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with chronic kidney disease undergoing peritoneal dialysis and hemodialysis over 1 year were enrolled
Key inclusion criteria (1 listed)
- peritoneal dialysis and hemodialysis patients
Key exclusion criteria (1 listed)
- a history of abdominal surgery or with a proton pump inhibitor before 1 month and a eradication of H. pylori were excluded
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
prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis
Time frame: 2 yrs
1 secondary outcome
risk factor for GERD in peritoneal dialysis and hemodialysis patients
Time frame: 2 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Hyun jung Song, Bechelor's principal investigator
Konyang 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 Gastroesophageal Reflux Disease, run by Song Kyung Ho at 1 site in South Korea.
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 1 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 6 Jul 2012. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of GERD among chronic kidney disease with peritoneal dialysis and hemodialysis (time frame: 2 yrs). 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 6 Jul 2012.