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REmoval of Free Light Chains. A COmpaRison of Three Different dialyzERs (RECORDER)

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ClinicalTrials.gov Identifier: NCT02950389
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriele Donati, St. Orsola Hospital

Brief Summary:

Immunoglobulin light chains are classified as middle molecule uremic toxins able to interact with B lymphocyte membranes leading to the activation of transmembrane signaling. The ensuing impairment of neutrophil function can contribute to the chronic inflammation state of uremic patients, and the increased risk of bacterial infections or vascular calcifications. The aim of this crossover observational study was to assess the difference in free light chain removal by three different hemodialysis filters in patients not affected by multiple myeloma.

Free light chain removal was compared in the polymethylmethacrylate (PMMA) membrane Filtryzer BK-F, the polyphenylene HFR17 filter and the conventional polysulfone filter F7 High Performance dialysers (HPS). Twenty chronic hemodialysis patients were enrolled. The patients were randomized into two groups of treatment lasting six weeks each. The dialysis sessions checked were the midweek sessions and the blood was drawn at times 0, 120' and 240'. Kappa (k) and lambda (l) light chain levels, beta2microglobulin (β2M), C reactive protein (CRP) and albumin were checked.


Condition or disease Intervention/treatment Phase
Complication of Hemodialysis Device: PMMA filter Device: HFR17 filter Device: F7 filter Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: REmoval of Free Light Chains in Hemodialysis Patients Without Multiple Myeloma. A Crossover COmpaRison of Three Different dialyzERs
Study Start Date : January 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Six bicarbonate dialysis session with PMMA dialysis filter for 2 weeks, followed by 2 weeks of 6 on-line HFR session with HFR17 dialysis filter, than 6 bicarbonate dialysis session for 2 weeks with F7 dialysis filter.
Device: PMMA filter
Device: HFR17 filter
Device: F7 filter
Experimental: Group B
Six on-line HFR session with HFR17 dialysis filter for 2 weeks, followed by 2 weeks of 6 o bicarbonate dialysis session with PMMA dialysis filter for 2 weeks, than 6 bicarbonate dialysis session for 2 weeks with F7 dialysis filter.
Device: PMMA filter
Device: HFR17 filter
Device: F7 filter



Primary Outcome Measures :
  1. Compare free light chain removal by three different hemodialysis filters in a cohort of chronic dialysis patients not affected by multiple myeloma [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. Compare beta 2 microglobulin removal by three different hemodialysis filters [ Time Frame: 45 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic hemodialysis patients
  • free light chain values >100 mg/L for k chains or >50 mg/L for lambda chains.
  • absence or <200 ml/die residual diuresis
  • fistula or central venous catheter with blood flow >250 ml/min.

Exclusion Criteria:

  • intradialytic hypotension
  • multiple myeloma
  • poly-allergy
  • HIV positivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950389


Locations
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Italy
Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital
Bologna, Italy
Sponsors and Collaborators
St. Orsola Hospital
Investigators
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Principal Investigator: Gabriele Donati, MD, PhD S.Orsola University Hospital, Nephrology Dialysis and Renal Transplantation Unit

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriele Donati, M.D. Ph.D., St. Orsola Hospital
ClinicalTrials.gov Identifier: NCT02950389     History of Changes
Other Study ID Numbers: 2016/GD/2
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gabriele Donati, St. Orsola Hospital:
PMMA
on-line HFR
free light chains
toxins
removal
hemodialysis