Kidney Failure, ChronicPhase 4NCT01315314
Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction
A Phase 4 study testing Balance, Fresenius Medical Care, Germany in people with Kidney Failure, Chronic and Disorders Associated With Peritoneal Dialysis, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effects of neutral pH and low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation and endothelial dysfunction markers in incident PD patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure, Chronic, Disorders Associated With Peritoneal Dialysis
- What is being tested?
- Balance, Fresenius Medical Care, Germany
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged over 18 years and less than 75 years
- Within 90 days of initiation of first renal replacement treatment for ESRD
- Selected for maintenance management by CAPD
- Having provided informed consent
- Physically and mentally capable of performing the therapy
Who cannot join
- Patients were excluded if deemed to have less than 80% likelihood of survival for at least 1 year
- episodes of peritonitis within prior 30 days
- any malignancy other than treated skin carcinoma
- uncontrolled congestive heart failure
- recent (within 60 days) myocardial infarction or cerebrovascular accident
- active systemic vasculitic disease including systemic lupus erythematosus, polyarteritis nodosa, ANCA-nephritis, active rheumatoid disease, or active venous thrombotic-embolic disease
Show all 9Show fewer
- any acute infection at the time of enrollment
- active or actively treated tuberculosis
- recent (within 30 days) systemic bacterial infection.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital
Daegu, 700-721
About this study
Official title: Effects of Neutral pH and Low Glucose Degradation Product-containing Peritoneal Dialysis Fluid on Systemic Markers of Inflammation and Endothelial Dysfunction: a Randomized, Controlled 1-year Follow-up Study
The purpose of this study is to evaluate the effects of neutral pH and low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation and endothelial dysfunction markers in incident PD patients.
Read the detailed description
New peritoneal dialysis fluids (PDF) with neutral pH and low glucose degradation products (GDPs) are used in patients on peritoneal dialysis (PD). Low GDP fluids are reported to be more biocompatible than conventional PDF. Determination of biocompatibility has mainly focused on local peritoneal effects; recently, there has been interest in evaluating the systemic biocompatibility of these fluids.
In recent analyses of two retrospective cohorts of Korean PD patients, significant survival advantage was shown for patients treated with the biocompatible PDF compared to patients treated with conventional PDF. However, the mechanisms of survival advantage with low GPD PDF in these observational studies are difficult to assess. Additionally, it is not clear that new PDFs favorably impact risk markers of cardiovascular disease (CVD).
Epidemiologic studies identified an independent association between inflammation and risk of cardiovascular events and mortality; this association has been confirmed in patients with advanced chronic kidney diseases (CKD).Other evidence showed that clinically overt vascular events are preceded by endothelial dysfunction and increases in circulating markers of endothelial activation, including vascular cellular adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1.Moreover, there is an association between inflammation and elevated levels of soluble VCAM-1 and ICAM-1 in patients with or at risk of atherosclerosis. Elevated levels of soluble adhesion molecules are found in ESRD patients, especially in patients with CVD and malnutrition.
The investigators hypothesized that conventional PDF as well as uremia itself lead to local peritoneal changes such as peritoneal neoangiogenesis and fibrosis, effects related to ultrafiltration failure and subsequently volume overload. In addition, direct effect of GDPs and/or increased systemic levels of AGEs activate endothelial cells and increase levels of vascular adhesion molecules and inflammation. Both local and systemic effects of PDF are possibly associated with increased cardiovascular risks and mortality in PD patients.
This study aims to examine the effects of neutral pH and low GDP-containing PDF on systemic inflammation and endothelial dysfunction in incident PD patients in a randomized, controlled study.
- Being tested
- Balance, Fresenius Medical Care, Germany
- Keywords
- Glucose degradation products, Inflammation, Endothelial dysfunction, Soluble adhesion molecules, Peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance, Fresenius Medical Care, GermanyDrug
Also called Balance, Fresenius Medical Care
low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)
| Study group | Role | What they receive |
|---|---|---|
| conventional PDF (Stay safe) | No intervention | Not described |
| low GDP PDF (Balance) | Active comparator | Not described Receives: Drug: Balance, Fresenius Medical Care, Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation-endothelial-dysfunction index (IEDI)
Inflammation-endothelial-dysfunction index (IEDI) is a composite score derived from measurement of serum levels of CRP (high sensitivity assay), soluble VCAM-1 and soluble ICAM-1. Changes between the groups will be tested by analysis of covariance (ANCOVA) with baseline values as covariates. Serial data will also be analyzed using a linear mixed model.
Measured: Baseline and 12 months
Secondary outcomes (14)
Individual component markers of IEDI
individual component markers of the IEDI including sICAM-1, sVCAM-1, and hs-CRP
Measured: Baseline and 12 months
RRF
residual renal function (RRF) as average of urea and creatinine clearances by 24 hour urine collection
Measured: Baseline and 12 months
peritoneal clearance
peritoneal clearance as weekly Kt/V urea and creatinine clearance
Measured: Baseline and 12 months
peritoneal ultrafiltration
peritoneal ultrafiltration volume
Measured: Baseline and 12 months
peritoneal transport status
dialysate-to-plasma ratio of creatinine at 4 hours of peritoneal equilibration test
Measured: Baseline and 12 months
serum albumin
Measured: Baseline and 12 months
LBM
lean body mass (LBM) estimated from creatinine kinetics
Measured: Baseline and 12 months
nPNA
normalized protein equivalent of nitrogen appearance (nPNA)
Measured: Baseline and 12 months
SGA
subjective global assessment (SGA) with a four item and seven-point scale
Measured: Baseline and 12 months
Blood pressure
systolic and diastolic blood pressure
Measured: Baseline and 12 months
use of antihypertensive medications
number of antihypertensive medications
Measured: Baseline and 12 months
peritonitis rates
peritonitis rates
Measured: 12 months
technique survival
technique survival by Kaplan-Meier survival analysis with Log-Rank test.
Measured: 12months
patient survival
patient survival by Kaplan-Meier survival analysis with Log-Rank test.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Fresenius Medical Care Korea
- Investigators
- Yong-Lim Kim, Professor, Study chair, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315314
- Sponsor's protocol ID
- IEDI MCS
- Other IDs
- A084001
- Status last verified
- Apr 2007
- First submitted
- 11 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neutral pH and Low Glucose Degradation Product-containing Peritoneal Dialysis Fluid on Systemic Markers of Inflammation and Endothelial Dysfunction: a Randomized, Controlled 1-year Follow-up Study
- ClinicalTrials.gov ID
- NCT01315314
- Acronym / sponsor ID
- IEDI MCS
- Keywords
- Glucose degradation products, Inflammation, Endothelial dysfunction, Soluble adhesion molecules, Peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Fresenius Medical Care Korea
- Study start
- Oct 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Mar 2011 (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 evaluate the effects of neutral pH and low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation and endothelial dysfunction markers in incident PD patients.
Detailed description
New peritoneal dialysis fluids (PDF) with neutral pH and low glucose degradation products (GDPs) are used in patients on peritoneal dialysis (PD). Low GDP fluids are reported to be more biocompatible than conventional PDF. Determination of biocompatibility has mainly focused on local peritoneal effects; recently, there has been interest in evaluating the systemic biocompatibility of these fluids.
In recent analyses of two retrospective cohorts of Korean PD patients, significant survival advantage was shown for patients treated with the biocompatible PDF compared to patients treated with conventional PDF. However, the mechanisms of survival advantage with low GPD PDF in these observational studies are difficult to assess. Additionally, it is not clear that new PDFs favorably impact risk markers of cardiovascular disease (CVD).
Epidemiologic studies identified an independent association between inflammation and risk of cardiovascular events and mortality; this association has been confirmed in patients with advanced chronic kidney diseases (CKD).Other evidence showed that clinically overt vascular events are preceded by endothelial dysfunction and increases in circulating markers of endothelial activation, including vascular cellular adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1.Moreover, there is an association between inflammation and elevated levels of soluble VCAM-1 and ICAM-1 in patients with or at risk of atherosclerosis. Elevated levels of soluble adhesion molecules are found in ESRD patients, especially in patients with CVD and malnutrition.
The investigators hypothesized that conventional PDF as well as uremia itself lead to local peritoneal changes such as peritoneal neoangiogenesis and fibrosis, effects related to ultrafiltration failure and subsequently volume overload. In addition, direct effect of GDPs and/or increased systemic levels of AGEs activate endothelial cells and increase levels of vascular adhesion molecules and inflammation. Both local and systemic effects of PDF are possibly associated with increased cardiovascular risks and mortality in PD patients.
This study aims to examine the effects of neutral pH and low GDP-containing PDF on systemic inflammation and endothelial dysfunction in incident PD patients in a randomized, controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional PDF (Stay safe) | No intervention | – |
| low GDP PDF (Balance) | Active comparator | Drug: Balance, Fresenius Medical Care, Germany |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged over 18 years and less than 75 years
- Within 90 days of initiation of first renal replacement treatment for ESRD
- Selected for maintenance management by CAPD
- Having provided informed consent
- Physically and mentally capable of performing the therapy
Key exclusion criteria (9 listed)
- Patients were excluded if deemed to have less than 80% likelihood of survival for at least 1 year
- episodes of peritonitis within prior 30 days
- any malignancy other than treated skin carcinoma
- uncontrolled congestive heart failure
- recent (within 60 days) myocardial infarction or cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance, Fresenius Medical Care, GermanyAlso: Balance, Fresenius Medical Carelow glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) | Drug | low GDP PDF (Balance) |
Primary outcome
Inflammation-endothelial-dysfunction index (IEDI)
Time frame: Baseline and 12 months
Inflammation-endothelial-dysfunction index (IEDI) is a composite score derived from measurement of serum levels of CRP (high sensitivity assay), soluble VCAM-1 and soluble ICAM-1. Changes between the groups will be tested by analysis of covariance (ANCOVA) with baseline values as covariates. Serial data will also be analyzed using a linear mixed model.
14 secondary outcomes
Individual component markers of IEDI
Time frame: Baseline and 12 months
RRF
Time frame: Baseline and 12 months
peritoneal clearance
Time frame: Baseline and 12 months
peritoneal ultrafiltration
Time frame: Baseline and 12 months
peritoneal transport status
Time frame: Baseline and 12 months
serum albumin
Time frame: Baseline and 12 months
LBM
Time frame: Baseline and 12 months
nPNA
Time frame: Baseline and 12 months
SGA
Time frame: Baseline and 12 months
Blood pressure
Time frame: Baseline and 12 months
use of antihypertensive medications
Time frame: Baseline and 12 months
peritonitis rates
Time frame: 12 months
technique survival
Time frame: 12months
patient survival
Time frame: 12 months
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 17 Mar 2011.
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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.
Yong-Lim Kim, Professor study chair
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balance, Fresenius Medical Care, Germany in people with Kidney Failure, Chronic and Disorders Associated With Peritoneal Dialysis, run by Kyungpook National University Hospital 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 5 inclusion and 9 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 17 Mar 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Inflammation-endothelial-dysfunction index (IEDI) (time frame: Baseline and 12 months). 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 17 Mar 2011.