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

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 - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098336

Enrollment

Registered

2025-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: 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 Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Patients scheduled for a kidney transplan 2. Patients unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
To measure the removal performance and albumin loss amount with middle flux dialyzer ELISIO-17M as compared to super high flux dialyzer ELISIO-17HXTimepoint: Time points at which the outcome will be assessed/estimated i.e. Albumin loss will be at week 5 and week 7	—

Secondary

Measure	Time frame
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 & albuminTimepoint: 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	—

Measure

Time frame

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 & albuminTimepoint: 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

—

Countries

India

Contacts

Public ContactDr Vijay Kher

Epitome Kidney Urology Institute & Lions Hospital

vijay.kher@epitomehospital.com01169058888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026