Clinical trial NCT04747067: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hemodiafiltration
Hemodialysis
Keywords: End stage renal disease (ESRD)
hemodiafiltration (HDF)
hemodialysis (HD)
Free light chains
Albumin loss
Kappa and lambda
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Free light chain reduction
timeFrame: 1 day of hemodialysis session
Secondary outcomes:
measure: Cumulative albumin loss
timeFrame: 1 day of hemodialysis session
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Governorate
Study officials:
affiliation: Faculty of Medicine, Ain Shams Univeristy.
name: Reem Sultan, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Ain Shams Univeristy
name: Hesham ElSayed, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Ain Shams Univeristy
name: Magdy ElSharkawy, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Ain Shams Univeristy
name: Waleed AbdelMohsen, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Ain Shams Univeristy
name: Shaimaa Zaki, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Ain Shams Univeristy
name: Ahmed Emara, PhD
role: STUDY_DIRECTOR
References:
citation: Bourguignon C, Chenine L, Bargnoux AS, Leray-Moragues H, Canaud B, Cristol JP, Morena M. Hemodiafiltration improves free light chain removal and normalizes kappa/lambda ratio in hemodialysis patients. J Nephrol. 2016 Apr;29(2):251-257. doi: 10.1007/s40620-015-0207-z. Epub 2015 May 29.
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. doi: 10.1186/s12882-016-0405-5.
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.
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.
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.
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.
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.
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.