Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Kidney Failure Clinical Trial

— hemodialysis  

Official title:

Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00633308
• Other study ID #: NxStage LongHD
• Status: Withdrawn
• Phase: Phase 2
• First received: February 21, 2008
• Last updated: February 29, 2016
• Start date: March 2008
• Est. completion date: February 2011

Study information

• Verified date: February 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of dialysate volume and treatment time on phosphage and calcium removal		4 treatments	Yes