Back to results

To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.

Primary Purpose

End Stage Renal Disease, Hemodiafiltration, Hemodialysis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

BIOPURE 260HF dialyzer

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Prevalent HD patients on regular hemodialysis sessions for >6 months 3 sessions/week of 4 hours duration.
Patients with Arterio-venous fistula as dialysis access.

Exclusion Criteria:

Patients with hemodialysis catheters.
Patients with active inflammation or infection.
Decompensated heart failure.
Liver Cell Failure ( Child B,C)
Patients with known malignancies.

Sites / Locations

Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High-flux Hemodialysis

Hemodiafiltration

Arm Description

patients treated by conventional hemodialysis

patients treated by online post-dilution hemodialysis

Outcomes

Primary Outcome Measures

Free light chain reduction

Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF.

Secondary Outcome Measures

Cumulative albumin loss

Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF

Full Information

NCT ID

NCT04747067

First Posted

February 6, 2021

Last Updated

March 11, 2022

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04747067

Brief Title

To Assess the Effect of HDF Versus High Flux Dialysis on Free Light Chains and Cumulative Albumin Loss, in End Stage Renal Disease Patients.

Official Title

The Effect of Hemodiafiltration Versus High Flux Dialysis On Free Light Chains Reduction And Its Relation To Albumin Loss.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

May 1, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Removal of uremic toxins is the main goal of HD, It was improved by using high volume convective technique with high flux (HF) dialyzer. This technique removes medium - large molecular weight solutes giving higher dialysis adequacy and consequently improving the quality of life. This study will assess the effect of hemodiafiltration (HDF) versus high flux dialysis on free light chains (FLC) reduction as a marker of HD adequacy and its relation to albumin loss using dialyzer effective surface area 2.6m2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Hemodiafiltration, Hemodialysis

Keywords

End stage renal disease (ESRD), hemodiafiltration (HDF), hemodialysis (HD), Free light chains, Albumin loss, Kappa and lambda

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

It is a pilot crossover study, 25 ESRD patients were dialyzed using dialyzer; BIOPURE 260 HF on a single session on two hemodialysis modalities (conventional HD and online post-dilution HDF) with washout period of 2 weeks using high flux dialyzers with maximum surface area 2.0 m2.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-flux Hemodialysis

Arm Type

Experimental

Arm Description

patients treated by conventional hemodialysis

Arm Title

Hemodiafiltration

Arm Type

Experimental

Arm Description

patients treated by online post-dilution hemodialysis

Intervention Type

Device

Intervention Name(s)

BIOPURE 260HF dialyzer

Intervention Description

Dialyzer with effective surface area 2.6 m2, High-flux polyethersulfone hollow fiber with steam sterilization, myoglobin sieving coefficient (SC) 0.7, membrane cutoff 40,000 Daltons (Allmed Medical Gmbh)

Primary Outcome Measure Information:

Title

Free light chain reduction

Description

Measurement of kappa (23KDa) and lambda (45 KDa)free light chains levels, pre and post dialysis session, in patients undergoing high-flux dialysis versus HDF.

Time Frame

1 day of hemodialysis session

Secondary Outcome Measure Information:

Title

Cumulative albumin loss

Description

Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF

Time Frame

1 day of hemodialysis session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prevalent HD patients on regular hemodialysis sessions for >6 months 3 sessions/week of 4 hours duration. Patients with Arterio-venous fistula as dialysis access. Exclusion Criteria: Patients with hemodialysis catheters. Patients with active inflammation or infection. Decompensated heart failure. Liver Cell Failure ( Child B,C) Patients with known malignancies.

Overall Study Officials: