Continuous Ambulatory Peritoneal DialysisNCT00728806
Biomarker for Peritoneal Ultrafiltration Failure
An observational study of Continuous Ambulatory Peritoneal Dialysis, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal dialysis (PD) patients with different types of peritoneal solute transport by differential proteomics techniques. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Continuous Ambulatory Peritoneal Dialysis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2007to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University
Who may be able to join
- Continuous ambulatory peritoneal dialysis patients whose primary disease is chronic glomerulonephritis, The range of age is 20 to 65 year old.
- serum albumin level ≥ 35 g/L.
- Residual GFR ≥ 2 ml/min/1.73 m2.
- 500 ml/d ≤ urine output ≤ 1000 ml/d.
- Subjects who agree to participate in the study and sign the informed consent.
Who cannot join
- Patients who are secondary nephropathy.
- Patients with congestive heart failure, angina, myocardial infarction, severe valvular heart disease, malignant hypertension, hypertensive encephalopathy or cerebrovascular accident.
- Patients with chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure
This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal dialysis (PD) patients with different types of peritoneal solute transport by differential proteomics techniques.
This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.
Read the detailed description
Ultrafiltration failure (UFF) is an important cause of technical failure in PD patients. It may develop over time and is, therefore, especially important in longterm PD. However, the study on UFF is very limited so far, there are still lack of biomarker for early detection and intervention of UFF.
Proteomics uses a rapidly evolving group of technologies to identify, quantify, and characterize a global set of proteins. It is characterized by high-throughput, high specificity and high-sensitivity. Therefore, proteomics has become a major focus of recent medical research.
This study will examine the peritoneal tissue, serum and dialysate proteins of continuous ambulatory peritoneal dialysis (CAPD) patients with different types of peritoneal solute transport by differential proteomics techniques. Correlation analysis will be used for the relationship between clinical data and the differential proteins, as well as verification of the differential proteins in the peritoneal tissue, serum and dialysate of patients with UFF. This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, Ultrafiltration failure, Biomarker, Proteomics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Ambulatory Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Case-control
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, M.D. & Ph.D., Principal investigator, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728806
- Sponsor's protocol ID
- SYSU-PROPDBM
- Status last verified
- May 2015
- First submitted
- 1 Aug 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Early Detection and Intervention of Peritoneal Ultrafiltration Failure
- ClinicalTrials.gov ID
- NCT00728806
- Acronym / sponsor ID
- SYSU-PROPDBM
- Keywords
- Continuous Ambulatory Peritoneal Dialysis, Ultrafiltration failure, Biomarker, Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Aug 2008 (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.
This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal dialysis (PD) patients with different types of peritoneal solute transport by differential proteomics techniques.
This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.
Detailed description
Ultrafiltration failure (UFF) is an important cause of technical failure in PD patients. It may develop over time and is, therefore, especially important in longterm PD. However, the study on UFF is very limited so far, there are still lack of biomarker for early detection and intervention of UFF.
Proteomics uses a rapidly evolving group of technologies to identify, quantify, and characterize a global set of proteins. It is characterized by high-throughput, high specificity and high-sensitivity. Therefore, proteomics has become a major focus of recent medical research.
This study will examine the peritoneal tissue, serum and dialysate proteins of continuous ambulatory peritoneal dialysis (CAPD) patients with different types of peritoneal solute transport by differential proteomics techniques. Correlation analysis will be used for the relationship between clinical data and the differential proteins, as well as verification of the differential proteins in the peritoneal tissue, serum and dialysate of patients with UFF. This study will be performed to identify the molecular difference between different types of peritoneal solute transport and explore biomarker for early detection as well as early intervention of peritoneal ultrafiltration failure.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital, Sun Yat-Sen University
Key inclusion criteria (5 listed)
- Continuous ambulatory peritoneal dialysis patients whose primary disease is chronic glomerulonephritis, The range of age is 20 to 65 year old.
- serum albumin level ≥ 35 g/L.
- Residual GFR ≥ 2 ml/min/1.73 m2.
- 500 ml/d ≤ urine output ≤ 1000 ml/d.
- Subjects who agree to participate in the study and sign the informed consent.
Key exclusion criteria (3 listed)
- Patients who are secondary nephropathy.
- Patients with congestive heart failure, angina, myocardial infarction, severe valvular heart disease, malignant hypertension, hypertensive encephalopathy or cerebrovascular accident.
- Patients with chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
Related trials for Continuous Ambulatory Peritoneal Dialysis
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
End-Stage Kidney Disease (ESKD), Hemodialysis
Recruiting
Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Children With End-stage Kidney Disease From Low-resource Settings
Children on Chronic Peritoneal Dialysis
RecruitingObservational study
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
End-stage Renal Disease
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.
Xueqing Yu, M.D. & Ph.D. principal investigator
1st Affiliated Hospital, Sun Yat-Sen 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 Continuous Ambulatory Peritoneal Dialysis, run by Sun Yat-sen 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 May 2015.