Efficacy of Newer Polyethersulfone Dialyzers in Comparison to Standard Dialyzers
Phase 3
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2021/01/030330
- Lead Sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients who are on a regular thrice-weekly HD schedule
Patients who have good vascular access (fistula or graft) i.e. effective blood flow ( > 300 ml/min)
Patients who achieved a dialysis dose (Kt/V) of 1.2 to 1.4 in at least 4 sessions in last 1 month
Patients who are on a stable anticoagulation, anemia and CKD-MBD management
Patients who can understand the nature and requirements of the clinical investigation and have given written informed consent
Exclusion Criteria
Patients who do not meet the inclusion criteria
Patients with active HBV, HCV, HIV infection
Patients who are severely malnourished patients (i.e. hypoalbuminemia defined as serum albumin concentration below 3.5 g/dL)
Patients who have an active infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Removal rate and clearance of endogenous markers e.g. Urea, Creatinine, phosphate, b2- microglobulin and albumin. <br/ ><br>Timepoint: 0,3,6,9 months
- Secondary Outcome Measures
Name Time Method Inter and intra-dialytic blood pressure control <br/ ><br>Erythropoietin Responsiveness factor or EPO index (average weekly EPO dose in IU per kg BW in the preceding 4 weeks divided by the last measured hemoglobin) <br/ ><br>Time-averaged serum albumin level <br/ ><br>Quality of life measures (SF-36/KDQOL-36 questionnaire) <br/ ><br>Adverse effects: AEs and SAEs using the Common Terminology Criteria for AEs (CTCAE v5.0)Timepoint: 0,3,6,9 months