Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT01722695
Brief 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
Study:
NCT01722695
Study Brief:
Protocol Section:
NCT01722695