NCT00633308

Brief Summary

The purpose of this sudy is to determined the effect of dialysate volume and treatment time on phosphate and calcium removal in stage V chronickidney disease patients treated by hemodialysis using the System One (NxStage Medical, Lawrence, MA)

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Typical duration for phase_2

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 21, 2008

Last Update Submit

February 29, 2016

Conditions

Kidney Failure

Keywords

hemodialysis

Outcome Measures

Primary Outcomes (1)

  • the effect of dialysate volume and treatment time on phosphage and calcium removal

    4 treatments

Study Arms (1)

A

EXPERIMENTAL

Long hemodialysis

Device: NxStage System One (NxStage Medical, Lawrence, MA)

Interventions

NxStage System One (NxStage Medical, Lawrence, MA)DEVICE

Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.

Also known as: The System One (NxStage Medical, Lawrence, MA)
A

Eligibility Criteria

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

You may qualify if:

  • Stage V chronic kidney patients with minimal or no residual renal functin

You may not qualify if:

  • Medically unstable
  • Hematocrit less than 28%
  • Hepatitis B positive, hepatitis C positive or HIV positive
  • Pregnant women
  • Minors below 18 years of age
  • Active psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael Kraus, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2008

First Posted

March 12, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2011

Last Updated

March 1, 2016

Record last verified: 2016-02