NCT03942744

Brief Summary

The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

March 5, 2019

Last Update Submit

March 29, 2022

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

HemodialysisEndothelial dysfunctionAtherogenesis

Outcome Measures

Primary Outcomes (1)

  • Effect of two different dialysis modalities (high flux vs online hemodiafiltration) on endothelial function markers: CD31,CD41,CD34; as measured by the percent of labeled cells obtained by flow cytometry.

    These parameters will assessed, in patients with chronic kidney disease (CKD5D), Blood will be drawn before the dialysis session following the scheduled of the protocol. The measuremets of CD31 CD41 CD34 will be performend by flow cytometry according to the standard methodology described in methods.

    6 months

Secondary Outcomes (3)

  • Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on hospitalization (hospital admission days/year).

    6 months

  • Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on Serum concentration of Fibroblast Growth Factor FGF23 (pg/ml) .

    6 months

  • Effect of two different dialysis modalities ( high flux vs online hemodiafiltration) on vascular injury related microRNAs (relative expression)

    6 months

Study Arms (2)

high-flux hemodialysis

NO INTERVENTION

high-flux hemodialysis cut-off membrane above 50

on-line hemodiafiltration

ACTIVE COMPARATOR

postdilutional on-line hemodiafiltration with a convective transport above 21 liters

Device: on-line hemodiafiltration

Interventions

on-line hemodiafiltrationDEVICE

on-line postdilutional hemodiafiltration with high convective transport above 21 liters

on-line hemodiafiltration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vascular access with a blood flow \> 300ml/min
  • Age \>18 \<80 years written informed consent

You may not qualify if:

  • Neoplasia
  • B hepatitis
  • Acute or chronic inflammation life expectance less than one year Included in living donor transplant list immunosupressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain

Location

Alejandro Martinmalo

Córdoba, Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • alejandro martin-malo, MD

    Maimónides Biomedical Research Institute of Córdoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: prospective randomized crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Chief of Dialysis Unit

Study Record Dates

First Submitted

March 5, 2019

First Posted

May 8, 2019

Study Start

November 8, 2018

Primary Completion

November 30, 2021

Study Completion

February 25, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

The individual data will be available in this report after deidenttification (text, tables, figures and appendices) to those researchers who provide a methodologically sound proposal and for meta-analysis.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available after the end of the study until one year the article publication.
Access Criteria
To obtain the data, a proposal must be sent to uicec@imibic.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES(2)