| CTRI Number |
CTRI/2021/01/030330 [Registered on: 07/01/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Newer Polyethersulfone Dialyzers in Comparison to Standard Dialyzers |
|
Scientific Title of Study
|
Biochemical Performance and Clinical Outcomes of "High Sieving" Polyethersulfone Dialyzers in Comparison to Standard Dialyzers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manas Ranjan Patel |
| Designation |
Assistant Professor |
| Affiliation |
SGPGI |
| Address |
Department of Nephrology and Renal Transplantation, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9918810550 |
| Fax |
|
| Email |
drmrpatel@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manas Ranjan Patel |
| Designation |
Assistant Professor |
| Affiliation |
SGPGI |
| Address |
Department of Nephrology and Renal Transplantation, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9918810550 |
| Fax |
|
| Email |
drmrpatel@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manas Ranjan Patel |
| Designation |
Assistant Professor |
| Affiliation |
SGPGI |
| Address |
Department of Nephrology and Renal Transplantation, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9918810550 |
| Fax |
|
| Email |
drmrpatel@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India |
| Address |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manas R Patel |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Department of Nephrology, C-Block, Room No-10
Lucknow
UTTAR PRADESH |
9918810550
drmrpatel@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SGPGI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dialysis with "high sieving" polyethersulfone dialyzers |
Dialysis with "high sieving" polyethersulfone dialyzers |
| Comparator Agent |
Dialysis with Standard Dialyzers |
Dialysis with Standard Dialyzers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Removal rate and clearance of endogenous markers e.g. Urea, Creatinine, phosphate, b2- microglobulin and albumin.
|
0,3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inter and intra-dialytic blood pressure control
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)
Time-averaged serum albumin level
Quality of life measures (SF-36/KDQOL-36 questionnaire)
Adverse effects: AEs and SAEs using the Common Terminology Criteria for AEs (CTCAE v5.0) |
0,3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hemodialysis is an established therapy for both acute and end stage renal disease. Central to hemodialysis therapy is a biocompatible hollow dialyzer membrane for diffusive and convective transport of uremic toxins. New production technology has led to refinement in dialysis membrane leading to crucial enhancements of membrane porosity, reducing flow resistance and improving transport across the membrane. In the newer membrane structure of polyethersulfone dialyzers, fiber support region underneath the inner surface has been “opened upâ€, optimizing porosity and therefore also the convective filtration (“flushingâ€) of larger uremic toxins such as b2-microglobulin or myoglobin. At the same time the size of the pores of the inner surface area was not increased to avoid flushing of albumin. In an hemodialysis treatment, reducing the inner fiber diameter from 200 micro m to 185 micro m acts to increase internal filtration, this results in a greater pressure difference between the blood and dialysate compartments. Thus, improved fiber design allows for high selective permeability for middle molecules i.e. better sieving of middle molecules such as b2-microglobulin while restricting the loss of vital molecule albumin. In addition, increased clearance of pro-inflammatory molecules in a broad molecular weight range may attenuate the chronic inflammatory state in patients on dialysis. As increased levels of β2-m and loss of albumin are associated with higher mortality risk, the use of these newer dialyzers may be associated with better clinical outcomes. Objective of the study is to assess the clinical and biochemical performance of the modified polyethersulfone dialyzer compared to standard dialyzers |