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

This study has been withdrawn prior to enrollment.
(No coordinator available to work on study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633308
First Posted: March 12, 2008
Last Update Posted: March 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Indiana University
  Purpose
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)

Condition Intervention Phase
Kidney Failure Device: NxStage System One (NxStage Medical, Lawrence, MA) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • the effect of dialysate volume and treatment time on phosphage and calcium removal [ Time Frame: 4 treatments ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Long hemodialysis
Device: NxStage System One (NxStage Medical, Lawrence, MA)
Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
Other Name: 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:

  1. Treatment for 8 hrs uding 40L of dialysate
  2. Treatment for 8 hrs using 60L of dialysate
  3. Treatment for 5 hrs using 40L of dialysate
  4. 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633308


Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Michael Kraus, M.D. Indiana University
  More Information

Responsible Party: Michael Kraus, M.D., Indiana University
ClinicalTrials.gov Identifier: NCT00633308     History of Changes
Other Study ID Numbers: NxStage LongHD
First Submitted: February 21, 2008
First Posted: March 12, 2008
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Indiana University:
hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases