Sorbent Treatment Prescriptions Pilot Study

Stopped early

Conditions studied: Renal Failure

In brief

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

Key facts

Study ID

NCT01437761

Run by

Renal Research Institute

People needed

12

Starts

2011-08-01

Expected to finish

2012-01-01

Last updated by the study team

2017-04-12

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

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

Full record on ClinicalTrials.gov

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