Phosphorus and Calcium Removal During Long Hemodialysis T... | NCT00633308

Studies
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions

NCT00633308

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

Mar 1, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Kidney Failure

Interventions

NxStage System One (NxStage Medical, Lawrence, MA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No coordinator available to work on study.

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Feb 21, 2008

First Submission Date that Met QC Criteria

Mar 11, 2008

First Posted Date

Mar 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2016

Last Update Posted Date

Mar 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Long hemodialysis	Device: NxStage System One (NxStage Medical, Lawrence, MA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NxStage System One (NxStage Medical, Lawrence, MA)	Device	Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the effect of dialysate volume and treatment time on phosphage and calcium removal		4 treatments

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Michael Kraus, M.D.	Indiana University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided