Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer

Launched by VANTIVE HEALTH LLC · Jun 4, 2018

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18 years or older.
• • Patients able to give informed consent (IC) after an explanation of the proposed study.
• • Patients who have Kt/Vurea \> 1.2 for the last 2 measurements, where the most recent Kt/Vurea measurement is taken within 4 weeks before or during study screening.
• • Patients with dialysis prescription (dialyzer, time, blood flow rate \[QB\], dialysis fluid flow rate \[QD\]) stable over 6 most recent treatments. The dialysis treatment duration time should be 3.5 - 4.5 hours per session, with QB of 220 - 300 mL/min and QD of 500 mL/min.
• • Patients who are on stable anticoagulation prescription and dose.
• • Patients with ESRD receiving chronic HD treatment with a history of thrice weekly HD, and at least 1 HDF session or HFHD, within 1 month prior to study.
• • Patients must be stable on in-center HD and/or HDF for \>3 months prior to study enrollment.
• • Patients who have an adequate arteriovenous fistula (AVF) or graft, capable of providing a blood flow rate of at least 220 mL/min.
• Exclusion Criteria:
• • Patients who have acute renal failure with the chance for recovery.
• • Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
• • Pregnant and lactating women.
• • Patients with positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
• • Patients with known hemodynamic instability, anemia (Hgb \< 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
• • Patients with active or ongoing infection per investigator's judgement.
• • Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm.
• • Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
• • Patients with a history of severe mental disorders.
• • Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks.
• • Patients who have had an allergic response to polyarylethersulfone (PAES) or polsulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes.
• • Patients with advanced liver, heart or pulmonary disease as judged by the Investigator.
• • Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.