Acid-Base Composition With Use of hemoDialysates

Inclusion Criteria

Subjects eligible to be entered into this study will meet all of the following criteria:

• Adult female or male patients; age ≥18 years.
• End stage renal disease (ESRD) patients treated for >90 days with the modality of maintenance hemodialysis and on a stable dialysis prescription for the prior month.
• Patients utilizing a hemodialysis vascular access of a functioning arteriovenous fistula (AVF) or graft (AVG) during the prior month. The patient's AVF/AVG must be considered in stable functioning condition and not be expected to require any surgical revision/intervention during participation in the trial.
• Patients with an average spKt/V of ≥1.2 during 30 days prior to screening as determined by historic monthly laboratory adequacy measurements; for patients with only one available spKt/V an average will not be performed. (Note: spKt/V should not be captured from dialysis machine adequacy measurements.)
• Screening hemoglobin level of ≥9 g/dL, and investigator considers hemoglobin levels to have been clinically stable for at least 30 days.
• A sodium bicarbonate basic dialysate prescription that has not had any changes for 30 days prior to randomization, and is anticipated to be unchanged during study participation as determined by the investigator.
• Unchanged heparin dosing regimen for the past 30 days prior to randomization and anticipated unchanged heparin dosing during participation in this clinical trial.
• No changes two weeks prior to randomization or anticipated changes throughout the study in any phosphate binders, calcium supplements, anticoagulant therapies that are not used for hemodialysis treatment (e.g. warfarin, dabigatran, apixaban, rivaroxaban and acetylsalicylic acid (ASA)), non-dialysate sodium bicarbonate and/or citrate based concomitant medications.
• If treated with systemic glucocorticoid/corticosteroid medications, no dose changes in the previous two months before randomization, or anticipated dose changes throughout the study duration; the dosing regimen should be consistent with maintenance therapy (i.e. not for an acute or active uncontrolled disease) as determined by the investigator. (Note: this criteria does not pertain to inhaled and/or topical glucocorticoid/corticosteroid therapies)
• During the two weeks prior to screening, an average of no more than 3.5 kg in pre-dialysis weight gain. In the event greater than 3.5 kg is noted, the investigator will discuss the specific medical history with the Medical Monitor prior to enrollment.
• Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

Patients that meet any of the following criteria will be ineligible for this study:

• Patients unable to provide a signed and dated informed consent for this clinical research study.
• Pregnant or lactating female patients.
• Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.
• 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.
• 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.
• 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.
• Uncontrolled clinically significant blood pressure as determined by the investigator within 30 days prior to screening.
• Active or recent bleeding disorder within the past 30 days.
• Screening or historic platelet count <100, 000 platelets per microliter (mcL) that was collected within 30 days prior to screening