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Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633308
Acronym
hemodialysis
Enrollment
0
Registered
2008-03-12
Start date
2008-03-31
Completion date
2011-02-28
Last updated
2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

hemodialysis

Brief summary

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)

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.

Interventions

DEVICENxStage 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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
the effect of dialysate volume and treatment time on phosphage and calcium removal4 treatments

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026