| CTRI Number |
CTRI/2025/12/098336 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study to check the overall performance of high flux dialyzer type Elisio17hx compared to Elisio17Min better removal of toxins while ensuring good quality blood dialysis along with the health and safety of patients receiving this treatment for End stage Kidney Disease |
|
Scientific Title of Study
|
Pilot prospective, open label, randomized, crossover, observational study t o evaluate the
efficacy in removal performance by the use of Dialyzer Elisio17hX as compared to Dialyzer Elisio17M,
in adult ESRD patients receiving thrice weekly hemodialysis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPID-IN01 v1.0 dated 1 june 2024 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Kher |
| Designation |
Chairman Nephrology |
| Affiliation |
Epitome Kidney Urology Institute & Lions Hospital |
| Address |
Division of Nephrology
Ground floor Room no 1
Ashoka Park Road, Opposite B Block, Khizarabad ,New Friends Colony, New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
01169058888 |
| Fax |
|
| Email |
vijay.kher@epitomehospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kher |
| Designation |
Chairman Nephrology |
| Affiliation |
Epitome Kidney Urology Institute & Lions Hospital |
| Address |
Division of Nephrology , Groung floor , Room no 1 , Ashoka Park Road, Opposite B Block Khizarabad New Friends Colony, New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
01169058888 |
| Fax |
|
| Email |
vijay.kher@epitomehospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kher |
| Designation |
Chairman Nephrology |
| Affiliation |
Epitome Kidney Urology Institute & Lions Hospital |
| Address |
Division of Nephrology , Ground floor, Room no 1 , Ashoka Park Road, Opposite , B Block Khizarabad New Friends Colony, New Delhi, India
New Delhi
DELHI
110025
India |
| Phone |
01169058888 |
| Fax |
|
| Email |
vijay.kher@epitomehospital.com |
|
|
Source of Monetary or Material Support
|
| Nipro Medical India Private Limited , Flat No 41, KRISHNA,#59 1st Avenue , 100 Feet Road , Ashok Nagar, chennai, Tamil Nadu, India, 600083 |
|
|
Primary Sponsor
|
| Name |
Nipro Medical India Private Limited |
| Address |
Flat No 41 Krishna 59 1st Avenue 100 Feet Road Ashok Nagar Cheenai Tamilnadu India Pincode 600083 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Dr Vijay Kher |
Epitome Kidney &Urology Institute &Lions hospital |
Principal Investigator
Dr Vijay kher, chairman Division of Nephrology , Ground floor, Room no 1
Ashoka park Road , Opposite B Block Khizarabad , New Freinds colony , New Delhi 110025
New Delhi
DELHI |
01169058888
vijay.kher@epitomehospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EPITOME ETHICS COMMEETIEE |
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 |
| Comparator Agent |
Hemo Dialyzer Elisio17hX Compared to Hemo Dialyzer Elisio17M |
Adult ESRD patients receiving thrice weekly hemodialysis
Frequency of intervention will be three times in a week
Total duration of intervention will be 56 weeks |
| Intervention |
Hemodialysis |
ESRD Patients receiving thrice weekly Hemodialysis
Frequency of intervention will be three times in a week
Total duration of intervention will be 56 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Above 18 years old
2.Residual renal function less than 500ml or Anuric
3.End Stage Renal Hemodialysis patient
4.Vascular access can be Catheter or AVF or AVG usage
5.Period of HD therapy (minimum 3 months )
6.Patients with Serum Albumin Less than 3.5g per liter |
|
| ExclusionCriteria |
| Details |
1. Patients scheduled for a kidney transplan
2. Patients unable to provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the removal performance and albumin loss amount with middle flux dialyzer ELISIO-17M as compared to super high flux dialyzer ELISIO-17HX |
Time points at which the outcome will be assessed/estimated i.e.
Albumin loss will be at week 5 and week 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of hemodialysis with two different dialyzers in terms of solute reduction rate
To determine the amount of clotting in the two different dialyzers by visual inspection
To determine the impact of two dialyzers on pre dialysis serum level of B2MG & albumin |
Solute reduction rate week 5 & week 7
Amount of clotting in the two different dialyzers by visual inspection will be at each dialysis session
Pre dialysis serum level of B2MG & albumin will be assessed & estimated at week 5, week 7, week 9, week 33, week 57
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/12/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Almost 5 million patients with chronic kidney disease are treated by hemodialysis worldwide. Hemodialysis has been the standard treatment for patients with chronic kidney disease for more than 70 years. Hemodialysis is a treatment in which blood is pumped out from the patient and passes through an artificial kidney, called a dialyzer or and returned to the patient. As blood passes through a series of hollow fibers in the dialyzer, and a fresh dialysate passes through the dialyzer in the opposite direction on the outside of the hollow fibers. Waste products of metabolism which build up in the blood in patients with chronic kidney disease then pass from the blood into the fresh dialysate by a process of diffusion whereby molecules move from a high concentration from the patients blood to one of low concentration the fresh dialysate Until 2013 In India only 10 percentage of patients requiring renal replacement therapy could undergo hemodialysis due to challenges in access to the treatment. Advanced modalities of treatments such as hemodiafiltration and dialysis with high flux dialyzer remain underutilized In Japan dialyzers were classified into five types based on their clearance for B2MG with a blood flow rate of 200 ml per min and a dialysate flow rate of 500 mL per min1 Type 1 is classified as low-flux membrane dialyzers less than 10 mL/min clearance Type 2 and 3 as high-flux membrane dialyzers Less than10 to Less than 30 mL/min and less than 30 to less than 50 mL permin clearance, respectively and Type 4 and 5 as super high flux membrane dialyzers less than 50 to less than 70 mL per min and less than 70 mL per min clearance, respectively Type 4 and 5 dialyzers are also classified as high-performance membrane HPM dialyzers due to their high flux rate permeability and biocompatibility Type V dialyzers are classified as High Performance Membrane dialyzers or so-called super high-flux dialyzers As an emerging trend the Japanese Society of Dialysis Therapy JSDT recommendations advise the use of High Performance Membrane dialyzers in patients on hemodialysis due to their ability to improve prognosis and decrease dialysis related complications Moreover according to a 3 year prospective cohort study of 242467 patients from JSDT data super high flux dialyzers were shown improve hemodialysis patients’ mortality The current modality of dialysis using low flux dialyzer is effective in removing small solutes through diffusion but clears only negligible amounts of middle-sized solutes, which are more difficult to remove by diffusion With the emerging trend in use of high flux dialyzers the current protocol aims at removal of a wide range of middle molecule uremic toxins with minimal albumin loss. While the use of super high flux dialyzer is based on their clearance of B2MG they may cause large amount of albumin leakage since these super high flux dialyzers have larger pores in addition they require high quality of dialysis fluid which meets standard dialysis fluid Endotoxin level less than 0.050EU per mL Bacterial countless than 0.1 CFU per mL which further emphasizes the need to evaluate the performance of the high flux dialyzers as compared to the other commercially available medium cut off dialysis membrane dialyzers This study would be used to assess their efficacy and other clinical outcomes such as better control of blood pressure phosphorus & anemia levels in hemodialysis patients along with improved long term cardiovascular mortality & morbidity optimizing dialysis treatment and improved outcomes in patients ensuring their overall health and safety , mainly By reducing the potential risk for increased loss of residual kidney function, diabetes and cardiovascular disease By creating an optimal balance between clearances of middle molecular weight (MW) molecules like 62 microglobulin and myoglobin and retention of albumin thereby providing good quality of dialysis treatment to both standard & vulnerable patient
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