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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This study has been withdrawn prior to enrollment.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.)
Information provided by:
Indiana University Identifier:
First received: February 21, 2008
Last updated: February 29, 2016
Last verified: February 2016
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: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00633308

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

Responsible Party: Michael Kraus, M.D., Indiana University Identifier: NCT00633308     History of Changes
Other Study ID Numbers: NxStage LongHD
Study First Received: February 21, 2008
Last Updated: February 29, 2016

Keywords provided by Indiana University:

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on April 26, 2017