Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Brief summary
study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months. Approximately 700 patients will be included.
Detailed description
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months. Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.
Interventions
DEVICEA synthetic high-flux dialyzer will be used for OL-HDF.
A synthetic high-flux dialyzer used for OL-HDF must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
DEVICEA medium cut-off dialyzer will be used for HDx.
A medium cut-off dialyzer used for HDx must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
Sponsors
Fundación Senefro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* End stage Renal Disease (ESRD) patients * Age\> 18 years old * HD therapy three times per week for 3 months at least and a maximum of 24 months.
Exclusion criteria
* No informed consent provided * Synthetic membrane allergy * Pregnant, breastfeeding, or planning to become pregnant * Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment. * Scheduled for living-donor transplantation within the study period * Patients with a significant residual renal function (defined as Urea clearance \>2,5 ml/min. * Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular morbility | every 3 months | Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis. |
Countries
Spain
Contacts
Primary ContactPatricia de Sequera Ortiz, PhD
Outcome results
None listed