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

NCT04747067 | Completed

• 1 other identifier: HD vs HDF
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cumulative albumin loss

  1 day of hemodialysis session

Study Arms (2)

High-flux Hemodialysis

EXPERIMENTAL

patients treated by conventional hemodialysis

Device: BIOPURE 260HF dialyzer

Hemodiafiltration

EXPERIMENTAL

patients treated by online post-dilution hemodialysis

Device: BIOPURE 260HF dialyzer

Interventions

BIOPURE 260HF dialyzer DEVICE

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)

Hemodiafiltration; High-flux Hemodialysis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Governorate, 0000, Egypt

Location

Related 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 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.

  PMID: 26022721 BACKGROUND

• 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.

  PMID: 27884120 BACKGROUND

• 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.

  PMID: 24603634 BACKGROUND

• 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.

  PMID: 29813181 BACKGROUND

• 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.

  PMID: 28452109 BACKGROUND

• 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.

  PMID: 29106652 BACKGROUND

• 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.

  PMID: 29507008 BACKGROUND

• 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.

  PMID: 30281131 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Reem Sultan, M.Sc

  Faculty of Medicine, Ain Shams Univeristy.

  PRINCIPAL INVESTIGATOR

• Hesham ElSayed, PhD

  Faculty of Medicine, Ain Shams Univeristy

  STUDY CHAIR

• Magdy ElSharkawy, PhD

  Faculty of Medicine, Ain Shams Univeristy

  STUDY CHAIR

• Waleed AbdelMohsen, PhD

  Faculty of Medicine, Ain Shams Univeristy

  STUDY DIRECTOR

• Shaimaa Zaki, PhD

  Faculty of Medicine, Ain Shams Univeristy

  STUDY DIRECTOR

• Ahmed Emara, PhD

  Faculty of Medicine, Ain Shams Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Internal Medicine and Nephrology

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 10, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

EG (1)