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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747067
• Other study ID #: HD vs HDF
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodiafiltration
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• BIOPURE 260HF dialyzer
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)

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Bourguignon C, Chenine L, Bargnoux AS, Leray-Moragues H, Canaud B, Cristol JP, Morena M. Hemodiafiltration improves free light chain removal and normalizes ?/? ratio in hemodialysis patients. J Nephrol. 2016 Apr;29(2):251-257. doi: 10.1007/s40620-015-0207-z. Epub 2015 May 29. — View Citation

Donati G, Moretti MI, Baraldi O, Spazzoli A, Capelli I, Comai G, Marchetti A, Sarma M, Mancini R, La Manna G. Removal of free light chains in hemodialysis patients without multiple myeloma: a crossover comparison of three different dialyzers. BMC Nephrol. 2016 Nov 25;17(1):193. — View Citation

Lamy T, Henri P, Lobbedez T, Comby E, Ryckelynck JP, Ficheux M. Comparison between on-line high-efficiency hemodiafiltration and conventional high-flux hemodialysis for polyclonal free light chain removal. Blood Purif. 2014;37(2):93-8. doi: 10.1159/000357968. Epub 2014 Mar 1. — View Citation

Maduell F. Hemodiafiltration versus conventional hemodialysis: Should "conventional" be redefined? Semin Dial. 2018 Nov;31(6):625-632. doi: 10.1111/sdi.12715. Epub 2018 May 29. Review. — View Citation

Nagai K, Tsuchida K, Ishihara N, Minagawa N, Ichien G, Yamada S, Hirose D, Michiwaki H, Kanayama HO, Doi T, Minakuchi J. Implications of Albumin Leakage for Survival in Maintenance Hemodialysis Patients: A 7-year Observational Study. Ther Apher Dial. 2017 Aug;21(4):378-386. doi: 10.1111/1744-9987.12526. Epub 2017 Apr 27. — View Citation

van Gelder MK, Abrahams AC, Joles JA, Kaysen GA, Gerritsen KGF. Albumin handling in different hemodialysis modalities. Nephrol Dial Transplant. 2018 Jun 1;33(6):906-913. doi: 10.1093/ndt/gfx191. Review. — View Citation

Wolley M, Jardine M, Hutchison CA. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018 May 7;13(5):805-814. doi: 10.2215/CJN.10110917. Epub 2018 Mar 5. Review. — View Citation

Wolley MJ, Hutchison CA. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii6-iii11. doi: 10.1093/ndt/gfy179. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day of hemodialysis session
Secondary	Cumulative albumin loss	Assessment of cumulative dialysate albumin loss by measuring albumin spent in dialysate -hourly- in patients undergoing high flux dialysis versus HDF	1 day of hemodialysis session