Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction

NCT ID: NCT01315314

Last Updated: 2011-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-04-30

Brief 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.

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.

Conditions

Kidney Failure, Chronic; Disorders Associated With Peritoneal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional PDF (Stay safe)

Group Type: NO_INTERVENTION

No interventions assigned to this group

low GDP PDF (Balance)

Group Type: ACTIVE_COMPARATOR

Balance, Fresenius Medical Care, Germany

Intervention Type: DRUG

low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)

Interventions

Balance, Fresenius Medical Care, Germany

low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)

Intervention Type: DRUG

Other Intervention Names

Balance, Fresenius Medical Care

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• any acute infection at the time of enrollment
• active or actively treated tuberculosis
• recent (within 30 days) systemic bacterial infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role: collaborator

Fresenius Medical Care Korea

INDUSTRY

Sponsor Role: collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital

Principal Investigators

Yong-Lim Kim, Professor

Role: STUDY_CHAIR

Kyungpook National University Hospital

Locations

Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital

Daegu, , South Korea

Countries

South Korea

Other Identifiers

A084001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IEDI MCS

Identifier Type: -

Identifier Source: org_study_id