Condition category
Urological and Genital Diseases
Date applied
11/08/2020
Date assigned
13/08/2020
Last edited
13/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dialysis is a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly. It often involves diverting blood to a machine to be cleaned.
Normally, the kidneys filter the blood, removing harmful waste products and excess fluid and turning these into urine to be passed out of the body.
The aim is to determine whether there are differences in the clinical outcomes of expanded hemodialysis (HDx) by Theranova® compared with conventional hemodialysis (HD) with high-flux dialysis machines in Colombia.

Who can participate?
Patients who underwent dialysis for at least 90 days between 01 September 2017 and 30 November 2017.

What does the study involve?
Review of patient records for outcomes at 2 years after dialysis.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Renal Therapy Services (Colombia)

When is the study starting and how long is it expected to run for?
May 2020 to December 2020

Who is funding the study?
Renal Therapy Services (Colombia)

Who is the main contact?
Prof. Mauricio Sanabria, mauricio_sanabria@baxter.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mauricio Sanabria

ORCID ID

http://orcid.org/0000-0002-5111-9832

Contact details

Carrera 7c bis # 141a -36
Bogota
110221002
Colombia
+57 3153663465
mauricio_sanabria@baxter.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RCS2020-001

Study information

Scientific title

Effectiveness of expanded hemodialysis (HDx) in Colombia: A retrospective clinical outcomes study

Acronym

COREXH-E

Study hypothesis

Expanded hemodialysis (HDx) could decrease frequency of hospitalization, hospital days and mortality compared with hemodialysis with high flux dialyzer.

Ethics approval

Approved 06/05/2020, Fundación Cardioinfantil Ethics committee (Bogota street 163A #13B-60, Bogotá, Colombia; +57 16672727; eticainvestigacion@cardioinfantil.org), ref: 15-2020

Study design

Retrospective observational multicentre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available (retrospective study)

Condition

End stage renal disease (Hemodialysis patients)

Intervention

Patient Population: Prevalent HD patients will be entered into two cohorts and followed for 2 years
Cohort 1: patients who receive treatment with HDx using Theranova dialyzers. These patients were enrolled in the original COREXH registry between 1st of September of 2017 until 30 of November of 2017.
Cohort 2: patients from the same clinics and time frame as Cohort 1 who receive treatment via conventional HD using a high-flux dialyzer. Patients with a high comorbidity index who were not expected to survive 6 months according to clinic notes will be excluded from Cohort 2 to control for exclusion of patients (with a life expectancy of less than six months as determined by his/her attending physician) in Cohort 1 of the COREXH registry.

Test and Observation Schedule: Patients in this study were either enrolled in COREXH registry study between 1 September and 30 November 2017 or received conventional High-Flux HD during the same time period. Cohort assignment will be determined according to whether the patient was prescribed with HDx during that period, or instead remained prescribed with high-Flux HD. After the enrollment date, each patient will be followed for two years, with the end date of follow-ups within the study on November 30, 2019.

Statistical Methods: Variables will be analysed descriptively and summarized for all eligible patients with available data. Continuous variables will be summarized by sample size (N), mean, standard deviation, median, minimum, maximum and compared using t tests with p values. Frequency and percentages will be provided for categorical variables and compared using chi-square test with p values.
Weighted samples (with IPTW) will be used for the cohort´s comparisons. For comparing hospitalization, mortality and non-fatal cardiovascular events between HDx and HF HD groups, Inverse probability of treatment weighting (IPTW) using the propensity score will be conducted according to the baseline variables that might indicate potential confounding within exposure and outcomes. The propensity score will be estimated using a multivariate logistic model in which the baseline variables (at the time of inclusion to the cohort) were predictors of the exposure status. After estimating the propensity score, the IPTW for each individual subject will be calculated, the balance of the baseline variables with standardized differences less than 0.1 will be evaluated.
Incidence rates for each group will be estimated; survival functions will be calculated using Kaplan-Meier estimators; comparisons of survival functions will be performed.

Additionally, statistical modelling will be performed on all patients to evaluate clinical outcomes. Hazard-Ratios (HRs) for comparing hazards between HDx and HF HD groups will be estimated using proportional hazards after adjusting for potential confounders.For variables related with count outcomes (e.g. days of hospitalization, number of phosphorus chelating agents, antihypertensive drugs and nutritional supplements), According to overdispersion assumption Poisson or negative binomial regression models will be used to estimate the strength of the association between type of dialysis and counts of events after adjusting for potential confounders.

Intervention type

Device

Phase

Phase III/IV

Drug names

1. Theranova dialyzer
2. Revaclear dialyzer
3. Polyflux dialyzer

Primary outcome measure

Measured using patient records at 2 year follow up:
1. Hospitalization events
2. Days spent in hospital

Secondary outcome measures

Measured using patient records at 2 year follow up:
1. Mortality
2. Medication consumption

Overall trial start date

06/05/2020

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. End stage renal disease
2. Prevalent HD patient defined as having received HD for 90 days or more at the time of the cohort’s inception (01 September 2017 through 30 November 2017)
3. Enrolled in the COREXH registry between 01 September 2017 and 30 November 2017, or were treated via conventional high-flux HD during the same time period at the same renal centers, and with the same model of dialysis care
4. Undergoing HD at least 3 times per week and a minimum duration of 4 hours per session
5. Received dialysis treatment in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,250

Participant exclusion criteria

1. High comorbidity measured as Charlson comorbidity Index > 8 and patients who were not expected to survive 6 months
2. Metastatic disease
3. Pregnancy
4. Younger than 18 years old

Recruitment start date

01/08/2020

Recruitment end date

15/09/2020

Locations

Countries of recruitment

Colombia

Trial participating centre

Renal Therapy Services dialysis network Colombia
Transversal 23 N 97-73 floor 6
Bogota
110221002
Colombia

Sponsor information

Organisation

Renal Therapy Services

Sponsor details

Transversal 23 #97-73
floor 6
Bogota
110221002
Colombia
+57 3202330486
Fabiola_aldana@baxter.com

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Renal Therapy Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

"Planned publication in a high-impact peer-reviewed journal" and scientific presentation in international congress.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/08/2020: Trial’s existence confirmed by Fundacion Cardioinfantil