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Sorbent Treatment Prescriptions Pilot Study (Sorb 2)

This study is currently recruiting participants.
Verified November 2012 by Renal Research Institute
Sponsor:
Collaborator:
Renal Solutions, Inc.
Information provided by (Responsible Party):
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01437761
First received: September 19, 2011
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Renal Failure
 Device: 2008 Sorbent System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • Treatment Adequacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)


Estimated Enrollment: 25
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
No Intervention: single pass hemodialysis
routine single-pass high-flux hemodialysis

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.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437761

Contacts
Contact: Rebecca Apruzzese, MS 646-672-4058 rapruzzese@rriny.com

Locations
United States, New York
Yorkville Dialysis Center Recruiting
New York, New York, United States, 10128
Contact: Laura Rosales, MD     212-870-9458     lrosales@rriny.com    
Sub-Investigator: Laura Rosales, MD            
Sponsors and Collaborators
Renal Research Institute
Renal Solutions, Inc.
Investigators
Principal Investigator: Peter Kotanko, MD Renal Research Institute
  More Information

No publications provided

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT01437761     History of Changes
Other Study ID Numbers: 150-11
Study First Received: September 19, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013