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

History of Changes

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:

MedlinePlus related topics: Calcium Dialysis

Drug Information available for: Phosphorus

U.S. FDA Resources

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:

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.

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

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 June 18, 2013

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