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Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions (hemodialysis)

Primary Purpose

Kidney Failure

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NxStage System One (NxStage Medical, Lawrence, MA)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    Long hemodialysis

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2008
    Last Updated
    February 29, 2016
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00633308
    Brief Title
    Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
    Acronym
    hemodialysis
    Official Title
    Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No coordinator available to work on study.
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    January 2010 (Anticipated)
    Study Completion Date
    February 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Indiana University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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)
    Detailed Description
    Ten patients will be recruited from those routinely treated in-center or at home using the Systerm One at the clinical centers. Each patient will be studiesd on 4 separate occastions. Treatments under the following conditions will each be performed on each study patient, at least one week apart: Treatment for 8 hrs uding 40L of dialysate Treatment for 8 hrs using 60L of dialysate Treatment for 5 hrs using 40L of dialysate Treatment for 5 hrs using 60L of dialysate Blood samples will be collected and assayed for the concentrations of urea, phosphate, calcium, bicarbonate, beta-2-microglobulin and albumin using standard assays.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Failure
    Keywords
    hemodialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Long hemodialysis
    Intervention Type
    Device
    Intervention Name(s)
    NxStage System One (NxStage Medical, Lawrence, MA)
    Other Intervention Name(s)
    The System One (NxStage Medical, Lawrence, MA)
    Intervention Description
    Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
    Primary Outcome Measure Information:
    Title
    the effect of dialysate volume and treatment time on phosphage and calcium removal
    Time Frame
    4 treatments

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stage V chronic kidney patients with minimal or no residual renal functin Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Kraus, M.D.
    Organizational Affiliation
    Indiana University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

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