Sorbent Treatment Prescriptions Pilot Study (Sorb2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437761
Recruitment Status : Terminated (Change of Institutional Affliation & Funding Changes)
First Posted : September 21, 2011
Last Update Posted : April 12, 2017
Renal Solutions, Inc.
Information provided by (Responsible Party):
Renal Research Institute

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.

Condition or disease Intervention/treatment
Renal Failure Device: 2008 Sorbent System

Detailed Description:

The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.

This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.

How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.

Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions
Study Start Date : August 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Group/Cohort Intervention/treatment
2008 Sorbent system
Hemodialysis with the 2008 Sorbent system
Device: 2008 Sorbent System
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).

Primary Outcome Measures :
  1. Treatment Adequacy [ Time Frame: 4 weeks ]
    spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
End-stage renal disease patients

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437761

United States, New York
Yorkville Dialysis Center
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Renal Solutions, Inc.
Principal Investigator: Peter Kotanko, MD Renal Research Institute

Responsible Party: Renal Research Institute Identifier: NCT01437761     History of Changes
Other Study ID Numbers: 150-11
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases