Patients with chronic kidney disease undergoing HD or HDF
Conditions
Interventions
Dialysis is performed using either the investigational drug PDLYT7 or the control drug, assigned by randomization, and examinations and observations specified in the protocol are conducted.
Sponsors
Mochizuki Hiromi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who are able to provide written informed consent to participate in the clinical trial of their own free will. 2.Patients aged 18 years or older but younger than 85 years at the time of obtaining informed consent. 3.Patients undergoing hemodialysis or hemodiafiltration three times per week, with each session lasting at least 3 hours, and with Quantity of Blood flow rate (QB) between 100-350 mL/min and Quantity of Dialysate plus Substitution flow rate (QD + QS) between 400-750 mL/min.
Exclusion criteria
Exclusion criteria: 1.Patients within 3 months of initiating dialysis at the time of obtaining informed consent for this study. 2.Patients who are considered unlikely to undergo stable HD/HDF throughout the study period. 3.Patients with severe cardiac disease. 4.Patients with severe hepatic dysfunction. 5.Patients with severe respiratory dysfunction. 6.Patients who are pregnant at the time of obtaining informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Removal rates of urea nitrogen (UN), creatinine (Cre), and uric acid (UA) | — |
Contacts
Public ContactHiromi Mochizuki
NIPRO CORPORATION
Outcome results
None listed