NCT03714386

Brief Summary

study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months. Approximately 700 patients will be included.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 5, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

September 28, 2018

Last Update Submit

August 1, 2019

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular morbility

    Occurring during the first 36 months after recruitment (consequence of dialisys) cardiovascular sintomatology (stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Ischemic Colitis.

    every 3 months

Study Arms (2)

expanded hemodialysis (HDx)

EXPERIMENTAL

HDx therapies must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription

Device: A medium cut-off dialyzer will be used for HDx.

online hemodiafiltration (HDF-OL)

ACTIVE COMPARATOR

OL-HDF therapies must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription

Device: A synthetic high-flux dialyzer will be used for OL-HDF.

Interventions

A synthetic high-flux dialyzer will be used for OL-HDF.DEVICE

A synthetic high-flux dialyzer used for OL-HDF must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription

online hemodiafiltration (HDF-OL)
A medium cut-off dialyzer will be used for HDx.DEVICE

A medium cut-off dialyzer used for HDx must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription

expanded hemodialysis (HDx)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details\>18 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage Renal Disease (ESRD) patients
  • Age\> 18 years old
  • HD therapy three times per week for 3 months at least and a maximum of 24 months.

You may not qualify if:

  • No informed consent provided
  • Synthetic membrane allergy
  • Pregnant, breastfeeding, or planning to become pregnant
  • Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment.
  • Scheduled for living-donor transplantation within the study period
  • Patients with a significant residual renal function (defined as Urea clearance \>2,5 ml/min.
  • Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

RECRUITING

Related Publications (1)

  • Blankestijn PJ. Do Medium Cut-Off Dialyzers Offer Any Clinical Benefit or Should We Focus on Hemodiafiltration? J Am Soc Nephrol. 2025 Jun 27;36(8):1473-1475. doi: 10.1681/ASN.0000000777. No abstract available.

    PMID: 40577061DERIVED

Study Officials

  • Rafael Perez Garcia, PhD

    Hospital Universitario Infanta Leonor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia de Sequera Ortiz, PhD

CONTACT

+34 911918000psequerao@senefro.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 22, 2018

Study Start

April 3, 2019

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

August 5, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)