Acid-Base Composition With Use of hemoDialysates

Exclusion Criteria

• •Patients that meet any of the following criteria will be ineligible for this study:
• •1. Patients unable to provide a signed and dated informed consent for this clinical research study.
• •2. Pregnant or lactating female patients.
• •3. Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.
• •4. Missed a scheduled outpatient dialysis treatment within two weeks prior to screening or anticipated to not attend any prescribed hemodialysis treatments during participation in the study.
• •5. Screening or historic laboratory values of aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) levels ≥ 2 times the upper limit of normal. These blood laboratory tests must have been performed within 30 days prior to screening or prior to randomization.
• •6. A screening or historic laboratory value of total bilirubin \>1.9 mg/dL that was collected within 30 days prior to screening or obtained before randomization.
• •7. Uncontrolled clinically significant blood pressure as determined by the investigator within 30 days prior to screening.
• •8. Active or recent bleeding disorder within the past 30 days.
• •9. Screening or historic platelet count \<100,000 platelets per microliter (mcL) that was collected within 30 days prior to screening or before randomization.
• •10. Chronic supplemental oxygen use within 30 days prior to randomization.
• •11. Current active and significant chronic obstructive pulmonary disease (COPD) as determined by the investigator.
• •12. Significant residual renal function as determined by the investigator. If the amount of residual renal function is in doubt, a 24 hour urine will be collected during the clinic admission to confirm the creatinine clearance. Decisions will be made after the results have been obtained as to the inclusion of data for these subjects.
• •13. Active malignancy or a malignancy within the past five years, with exceptions for basal and squamous cell carcinoma.
• •14. Active and clinically uncontrolled autoimmune disease as determined by the investigator. Subjects with controlled autoimmune diseases must be considered to be clinically stable in the opinion of the investigator (e.g. subjects with systemic lupus erythematosus (SLE) and no recent flares are not excluded). The investigator will consult with the referring physician if it is necessary to confirm the stability of an autoimmune disease.
• •15. Diagnosed with human immunodeficiency virus (HIV).
• •16. Diagnosed with congestive heart failure (CHF) class III or IV as classified by the New York Heart Association (NYHA) (refer to Appendix A) within the past 60 days.
• •17. Planned or anticipated need for any surgical procedures during participation in the study.
• •18. Current or recent illicit drug use or alcohol abuse as determined by the investigator.
• •19. Subjects that have any significant medical condition as determined by the investigator, which make her/him ineligible for the study (e.g. clinically significant vomiting on dialysis which affects acid-base status).
• •20. Any condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures and visits.
• •21. Treatment with an investigational drug, device or intervention within 30 days prior to and during participation in this clinical trial.