Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Rockwell Medical Technologies, Inc.
* A total of 12 subjects on standard 3X/week hemodialysis will be studied in 2 groups (6 subjects per group) * 2 primary dialyzer membranes will be studied.: * Polyamide Membrane (Gambro Polyflux series: 17R and 21R) * Cellulose Triacetate (Baxter CT series: CT-190) * Each 1-week treatment cycle will include 3 haemodialysis (HD) sessions per subject, including 2 study treatment-HD sessions and 1 non-treatment-HD session per subject. Treatment-HD sessions will be conducted midweek and end-of-week (i.e. Dialysis days 3 and 5 of each week with a 1 day interdialytic interval) to avoid excessive fluid shifts due to the increased UF needed during the non-treatment HD session (conducted at beginning of the week; HD day 1). * Within each group, each subject will be randomized to 1 of 6 treatment sequences. The treatments to be investigated are: Control; new dialyzer, reused dialyzer, low blood flow/dialysate flow, Low bicarbonate concentration and a different synthetic dialyzer membrane (PAES) * Blood for a complete serum iron profile over time will be obtained during the new dialyzer (SFP/standard bicarbonate/new dialyzer/ high Qb and Qd) for all subjects. This will necessitate approximately a 24-hour inpatient confinement to obtain blood at specified time intervals after dialysis is completed. Blood for a partial iron profile will be collected during the dialysis sessions at all other dialysis sessions. * Each of the 6 enrolled subjects per dialyzer membrane type will be assigned to a different sequence of treatments to help ensure that the treatment sequence does not affect the analysis (Note: the first dialysis sessions of each of the 3 study weeks, i.e. HD1, HD4 and HD7, are non-study related sessions during which no study procedures are performed except for adverse event collection. * Patients should not be receiving any of the following medications from screening through the end of the study: * Oral iron preparations, including multivitamin supplements containing iron * Intravenous iron preparations * Doses of ESA's should not be changed from screening to the end of the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
