Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions - Full Text View

Sponsored by:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00633308

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dialysis Kidney Failure

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
A: Experimental 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.

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

Keywords provided by Indiana University:

hemodialysis

Study placed in the following topic categories:

Calcium, Dietary
Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009