Performance Comparison of Revaclear With Larger Dialyzer (NCT01722695) | Clinical Trial Compass
CompletedNot Applicable
Performance Comparison of Revaclear With Larger Dialyzer
Austria30 participantsStarted 2012-11
Plain-language summary
The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area.
Study design: open, randomized, cross-over, multicentric, controlled prospective
Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs
Patients/sample size: 30 adult chronic hemodialysis patients
Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers.
Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss
Primary variable: dialysis dose Kt/V urea
Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin
Safety variable: albumin loss, blood count
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months
* patients aged 18 years or more
* written consent to participate in the study (informed consent)
* dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min
Exclusion Criteria:
* single-needle dialysis
* pregnant and lactating women
* participation in other interventional studies less than 3 months prior to study start
* non-compliance with the dialysis prescription
* hematocrit less than 28%
* hospitalization
* antibiotic therapy
* active infection
* active cancer
* known positive serology for HIV, hepatitis B or C
* serious hemostasis disorders
* any comorbidity possibly conflicting with the study purpose or procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.