Sorbent Treatment Prescriptions Pilot Study (Sorb2)

Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions

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

Study Overview

• Status: Terminated
• Conditions: Renal Failure
• Intervention / Treatment: 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
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Yorkville Dialysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

End-stage renal disease patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Adequacy	spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)	4 weeks

Collaborators and Investigators

• Sponsor: Renal Research Institute
• Collaborators: Renal Solutions, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 150-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No