NCT01315314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

March 17, 2011

Status Verified

April 1, 2007

Enrollment Period

2.5 years

First QC Date

March 11, 2011

Last Update Submit

March 16, 2011

Conditions

Kidney Failure, ChronicDisorders Associated With Peritoneal Dialysis

Keywords

Glucose degradation productsInflammationEndothelial dysfunctionSoluble adhesion moleculesPeritoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 12 months

Secondary Outcomes (14)

  • Individual component markers of IEDI

    Baseline and 12 months

  • RRF

    Baseline and 12 months

  • peritoneal clearance

    Baseline and 12 months

  • peritoneal ultrafiltration

    Baseline and 12 months

  • peritoneal transport status

    Baseline and 12 months

  • +9 more secondary outcomes

Study Arms (2)

conventional PDF (Stay safe)

NO INTERVENTION

low GDP PDF (Balance)

ACTIVE COMPARATOR
Drug: Balance, Fresenius Medical Care, Germany

Interventions

Balance, Fresenius Medical Care, GermanyDRUG

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

Also known as: Balance, Fresenius Medical Care
low GDP PDF (Balance)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, ChronicInflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong-Lim Kim, Professor

    Kyungpook National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

October 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

March 17, 2011

Record last verified: 2007-04

Locations

KR(1)