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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Indiana University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00633308
First received: February 21, 2008
Last updated: March 11, 2008
Last verified: March 2008
  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: 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: March 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633308

Contacts
Contact: Michael Kraus, M.D. 317-274-5292 mkraus@iupui.edu
Contact: Qian Li 317-278-3139 li@iupui.edu

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

No publications provided

Responsible Party: Michael Kraus, M.D., Indiana University
ClinicalTrials.gov Identifier: NCT00633308     History of Changes
Other Study ID Numbers: NxStage LongHD
Study First Received: February 21, 2008
Last Updated: March 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014