NCT01437761

Brief Summary

This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

September 19, 2011

Last Update Submit

April 10, 2017

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • Treatment Adequacy

    spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)

    4 weeks

Study Arms (1)

2008 Sorbent system

Hemodialysis with the 2008 Sorbent system

Device: 2008 Sorbent System

Interventions

2008 Sorbent SystemDEVICE

2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).

2008 Sorbent system

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End-stage renal disease patients

You may qualify if:

  • age \</=18 years
  • end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for \</= 6 months at time of enrollment
  • well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of \>/= 300 mL/min
  • ability to understand the English language

You may not qualify if:

  • Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
  • Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
  • Active Infections
  • Hepatitis B
  • Any other active infection that has required antibiotic treatment in the preceding eight weeks
  • Pre-study lab values of any of the following (in the most recent routine lab work)
  • Sodium - Na+ \> 150 mmol/L, Na+ \< 132 mmol/L
  • Potassium - K+ \> 6.5 mmol/L, K+ \< 3.5 mmol/L
  • Total Calcium - Ca \> 12 mg/dL (3 mmol/L), total Ca \< 7.2 mg/dL (1.8 mmol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Peter Kotanko, MD

    Renal Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 21, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)