NCT00714662

Brief Summary

To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

July 9, 2008

Last Update Submit

July 11, 2008

Conditions

End-Stage Renal Disease

Keywords

high flux hemodialysis

Outcome Measures

Primary Outcomes (1)

  • blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy

    6 months

Interventions

high flux hemodialyzer (FX-60, FX-80 or FX-100)DEVICE

three sessions per week

Also known as: FX-60, FX-80 or FX-100

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
  • Age: 18\~80 years old.
  • Blood flow during dialysis ≧ 250ml/min

You may not qualify if:

  • Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
  • Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
  • Bacteremia, myocardial infarction or stroke in previous 3 months.
  • Known diagnosis with dialysis related amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

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

  • Yung-Ming Chen, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Ming Chen, M.D.

CONTACT

00886-2-23123456chenym@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

July 14, 2008

Record last verified: 2008-07

Locations

TW(1)