NCT01202708

Brief Summary

This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

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

August 1, 1997

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

4.7 years

First QC Date

September 14, 2010

Last Update Submit

March 6, 2025

Conditions

Chronic Renal Failure

Keywords

chronic renal failurehemodiafiltration

Outcome Measures

Primary Outcomes (1)

  • Primary Goal: To assess the safety and efficacy of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA for the treatment of chronic renal failure.

    6 months

Interventions

On line hemofiafiltrationDEVICE

hemodiafiltration with the Gambro AK 200 ULTRA

Also known as: Gambro AK 200 ULTRA
On line hemodiafiltrationDEVICE

On line hemodiafiltration with the Gambro AK 200 ULTRA System

Also known as: Gambro AK 200 ULTRA System

Eligibility Criteria

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

You may qualify if:

  • Subject received chronic dialysis therapy
  • Subject was stable on three dialysis sessions per week
  • Subject was able to understand and sign the informed consent

You may not qualify if:

  • ) On chronic renal replacement therapy for less than three (3) months 2) Hospitalization for reasons other than vascular access complications in the past three (3) months 3) HIV + 4) Hepatitis B+ 5) Pregnancy, verified by pregnancy test for women of child bearing potential 6) Access recirculation \> 10% 7) Hematocrit less than 26% 8) History of non compliance 9) Pediatric patients, defined as less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

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

  • Dr. Susie Q. Lew, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

August 1, 1997

Primary Completion

April 1, 2002

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

US(1)