Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis
Crossover Study of Three Groups Comparing the Efficacy of Uremic Toxins Clearance of Expanded Hemodialysis With Two Hemodialysis Membranes for Conventional Hemodialysis and Hemodiafiltration
1 other identifier
interventional
23
1 country
1
Brief Summary
The aim of this study is to quantify the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx (expanded hemodialysis), HDc (high-flux conventional hemodialysis), or HDF (hemodiafiltration). And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedSeptember 17, 2021
September 1, 2021
4 months
March 3, 2021
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
B2-microglobulin reduction rate
B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF.
At final of each period of ET (4 weeks)
Secondary Outcomes (5)
Urea reduction rate
At final of each period of ET (4 weeks)
Phosphorus reduction rate
At final of each period of ET (4 weeks)
Interleukin 6 reduction rate
At final of each period of ET (4 weeks)
P-cresol reduction rate
At final of each period of ET (4 weeks)
Tumor necrosis factor-a reduction rate
At final of each period of ET (4 weeks)
Study Arms (3)
Hemodiafiltration
ACTIVE COMPARATORExpanded hemodialysis
EXPERIMENTALConventional high-flux hemodialysis
EXPERIMENTALInterventions
* Single-use Theranova 400 Dialyzer * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 500 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight
* Single-use high-flux hemodialyzer * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 500 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight
* Single-use high-flux hemodialyzer * Post-dilution mode * Minimum convective volume of 23 L * Blood flow (Qb) minimum of 300 mL/min * Dialysis flow (Qd) 700 mL/min * Minimum therapy time of 4 hours * Ultrafiltration necessary to achieve dry weight
Eligibility Criteria
You may qualify if:
- Over 18 years
- Anuric patients (residual urinary volume ≤ 100 mL/24 h)
- Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
- Without modification of their prescription in the last three months
- Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
- Letter of acceptance to enter the protocol and a signed informed consent.
You may not qualify if:
- Under 18 years
- Active intake or intake in the last six months of immunosuppressants or systemic steroids
- Active autoimmune disease
- Diagnosis of neoplasia or active oncological disease
- Hypoalbuminemia (\< 3.2 g/dL)
- Pregnancy or lactation
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080, Mexico
Related Publications (5)
Belmouaz M, Diolez J, Bauwens M, Duthe F, Ecotiere L, Desport E, Bridoux F. Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules . Clin Nephrol. 2018 Jan;89 (2018)(1):50-56. doi: 10.5414/CN109133 .
PMID: 28853700BACKGROUNDRonco C. The Rise of Expanded Hemodialysis. Blood Purif. 2017;44(2):I-VIII. doi: 10.1159/000476012. Epub 2017 May 10.
PMID: 28486230BACKGROUNDRonco C, Marchionna N, Brendolan A, Neri M, Lorenzin A, Martinez Rueda AJ. Expanded haemodialysis: from operational mechanism to clinical results. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii41-iii47. doi: 10.1093/ndt/gfy202.
PMID: 30281134BACKGROUNDZickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PMID: 28085888BACKGROUNDKirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
PMID: 27587605BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Correa-Rotter, MD
Head Departament of Nephrology and Mineral Metabolism,
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 8, 2021
Study Start
May 10, 2021
Primary Completion
September 6, 2021
Study Completion
January 1, 2022
Last Updated
September 17, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share