Hemodialysis-Associated PruritusNCT05698420
Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
An observational study of Hemodialysis-Associated Pruritus and Malnutrition-Inflammation-Cachexia Syndrome, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis-Associated Pruritus, Malnutrition-Inflammation-Cachexia Syndrome, Restless Legs Syndrome
- What is being tested?
- Dialysis using the Theranova-400 device. and Dialysis using the FX80 device.
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prevalent patients who are receiving hemodialysis treatment three times a week and are otherwise in stable condition.
Who may be able to join
- Chronic hemodialysis patients
- Patients continuing the hemodialysis program for at least 3 months
- Patients over 18 years of age
Who cannot join
- Patients with advanced heart failure, malignancy, terminal illness
- Patients with active infectious disease
- Acute hemodialysis patients
- Patients vascular access dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mehmet Akif Inan Training and Research Hospital
Sanliurfa, Karaköprü, 63000
About this study
In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.
Read the detailed description
The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;
Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.
Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.
The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)
- Conditions
- Hemodialysis-Associated Pruritus, Malnutrition-Inflammation-Cachexia Syndrome, Restless Legs Syndrome, Anemia of Chronic Kidney Disease, Depressive Disorder
- Being tested
- Dialysis using the Theranova-400 device., Dialysis using the FX80 device.
- Medical subject headings
- Restless Legs Syndrome, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis using the Theranova-400 device.Device
Patients receive hemodialysis treatment using the Theranova-400 dialyzer.
Dialysis using the FX80 device.Device
Patients receive hemodialysis treatment using the FX80 dialyzer.
| Study group | Role | What they receive |
|---|---|---|
| The Theranova 400 group, also known as the MCO group. | Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device. Receives: Device: Dialysis using the Theranova-400 device. | |
| The FX80 group, also known as the high-flux group. | Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device. Receives: Device: Dialysis using the FX80 device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition-inflammation score (MIS)
At the start of the study, the malnutrition-inflammation score will be recorded. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Measured: Prior to randomization, at the start of the study.
Malnutrition-inflammation score (MIS)
The malnutrition-inflammation score will be recorded at the conclusion of the study. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Measured: At the end of the 6th month after randomization.
Depressive disorder
At the start of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Measured: Prior to randomization, at the start of the study.
Depressive disorder
At the conclusion of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Measured: At the end of the 6th month after randomization.
Uremic pruritus
At the start of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Measured: Prior to randomization, at the start of the study.
Uremic pruritus
At the conclusion of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Measured: At the end of the 6th month after randomization.
Restless leg syndrome
At the start of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Measured: Prior to randomization, at the start of the study.
Restless leg syndrome
At the conclusion of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Measured: At the end of the 6th month after randomization.
Appetite
At the start of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.
Measured: Prior to randomization, at the start of the study.
Appetite
At the conclusion of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.
Measured: At the end of the 6th month after randomization.
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: March 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: April 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: May 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: June 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: July 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: August 2020
Hemoglobin
Hemoglobin levels will be measured on a monthly basis.
Measured: September 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: March 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: April 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: May 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: June 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: July 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: August 2020
Erythropoietin Doses
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Measured: September 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: March 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: April 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: May 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: June 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: July 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: August 2020
Phosphorus levels control
Serum phosphorus levels will be tested on a monthly basis.
Measured: September 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: March 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: April 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: May 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: June 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: July 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: August 2020
Parathyroid hormone levels control
Serum parathyroid hormone levels will be tested on a monthly basis.
Measured: September 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2020
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis-Associated PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuncay Sahutoglu, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Investigators
- Tuncay Sahutoglu, M.D., Principal investigator, Mehmet Akif Inan Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698420
- Sponsor's protocol ID
- MCOx_MAIEAH_001
- Status last verified
- May 2024
- First submitted
- 5 Jan 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05698420
- Acronym / sponsor ID
- MCOx_MAIEAH_001
- Conditions
- Hemodialysis-Associated Pruritus, Malnutrition-Inflammation-Cachexia Syndrome, Restless Legs Syndrome, Anemia of Chronic Kidney Disease, Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.
Detailed description
The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;
Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.
Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.
The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Theranova 400 group, also known as the MCO group. | – | Device: Dialysis using the Theranova-400 device.Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device. |
| The FX80 group, also known as the high-flux group. | – | Device: Dialysis using the FX80 device.Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prevalent patients who are receiving hemodialysis treatment three times a week and are otherwise in stable condition.
Key inclusion criteria (3 listed)
- Chronic hemodialysis patients
- Patients continuing the hemodialysis program for at least 3 months
- Patients over 18 years of age
Key exclusion criteria (4 listed)
- Patients with advanced heart failure, malignancy, terminal illness
- Patients with active infectious disease
- Acute hemodialysis patients
- Patients vascular access dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysis using the Theranova-400 device.Patients receive hemodialysis treatment using the Theranova-400 dialyzer. | Device | The Theranova 400 group, also known as the MCO group. |
| Dialysis using the FX80 device.Patients receive hemodialysis treatment using the FX80 dialyzer. | Device | The FX80 group, also known as the high-flux group. |
Primary outcome
Malnutrition-inflammation score (MIS)
Time frame: Prior to randomization, at the start of the study.
At the start of the study, the malnutrition-inflammation score will be recorded. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Malnutrition-inflammation score (MIS)
Time frame: At the end of the 6th month after randomization.
The malnutrition-inflammation score will be recorded at the conclusion of the study. This score ranges from 0 to 30, with higher scores indicating worse outcomes.
Depressive disorder
Time frame: Prior to randomization, at the start of the study.
At the start of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Depressive disorder
Time frame: At the end of the 6th month after randomization.
At the conclusion of the study, the Beck's depression scale will be recorded. This score ranges from 0 to 63, with higher scores indicating worse depression.
Uremic pruritus
Time frame: Prior to randomization, at the start of the study.
At the start of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Uremic pruritus
Time frame: At the end of the 6th month after randomization.
At the conclusion of the study, the visual analog scale for pruritus will be recorded. This score ranges from 0 to 10, with higher scores indicating worse itching.
Restless leg syndrome
Time frame: Prior to randomization, at the start of the study.
At the start of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Restless leg syndrome
Time frame: At the end of the 6th month after randomization.
At the conclusion of the study, the Restless Leg Syndrome screening questionnaire will be administered. This score ranges from 0 to 40, with higher scores indicating worse symptoms.
Appetite
Time frame: Prior to randomization, at the start of the study.
At the start of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.
Appetite
Time frame: At the end of the 6th month after randomization.
At the conclusion of the study, the visual analog scale of appetite will be recorded. This score ranges from 0 to 5, with higher scores indicating better appetite.
Hemoglobin
Time frame: March 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: April 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: May 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: June 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: July 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: August 2020
Hemoglobin levels will be measured on a monthly basis.
Hemoglobin
Time frame: September 2020
Hemoglobin levels will be measured on a monthly basis.
Erythropoietin Doses
Time frame: March 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: April 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: May 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: June 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: July 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: August 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Erythropoietin Doses
Time frame: September 2020
Weight-adjusted doses of erythropoietin will be prescribed on a monthly basis.
Phosphorus levels control
Time frame: March 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: April 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: May 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: June 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: July 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: August 2020
Serum phosphorus levels will be tested on a monthly basis.
Phosphorus levels control
Time frame: September 2020
Serum phosphorus levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: March 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: April 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: May 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: June 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: July 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: August 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Parathyroid hormone levels control
Time frame: September 2020
Serum parathyroid hormone levels will be tested on a monthly basis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuncay Sahutoglu, M.D. principal investigator
Mehmet Akif Inan Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis-Associated Pruritus and Malnutrition-Inflammation-Cachexia Syndrome, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition-inflammation score (MIS) (time frame: Prior to randomization, at the start of the study.). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.