Kidney FailureNCT03836508
Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
A study testing Medium cut-off and High-Flux in people with Kidney Failure and Renal Insufficiency, Chronic, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Failure, Renal Insufficiency, Chronic, Dialysis Related Complication
- What is being tested?
- Medium cut-off and High-Flux
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Jul 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are older than 18 years and younger than 65 years
- patient with end-stage renal disease, hemodialysis more than 6 months
- patients under hemodialysis with high-flux dialyzer more than 3 months
- patients willing to participate after given fair and clear information about study
Who cannot join
- patients living with Hepatitis B or C,
- patients with malignancy
- patients under immunosuppressive treatment
- patients with autoimmune diseases such as systemic lupus erythematosus, etc.
- patients with active infections
- patients planned to have a kidney transplantation in 6 months
- patients having vascular access problems
- patients planned to transfer to another center
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.
- Being tested
- Medium cut-off, High-Flux
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium cut-offDevice
All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min
High-FluxDevice
All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp.
Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min
| Study group | Role | What they receive |
|---|---|---|
| Medium cut-off | Active comparator | Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers. Receives: Device: Medium cut-off; Device: High-Flux |
| High-flux | Active comparator | High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers. Receives: Device: Medium cut-off; Device: High-Flux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pre and post-dialysis of Interleukin (IL) 17-A
Comparison of pre and post-dialysis of IL-17A
Measured: 3 months
Secondary outcomes (15)
Comparison of pre and post-dialysis of IL-10
Comparison of pre and post-dialysis of IL-10
Measured: 3 months
Comparison of pre and post-dialysis of Interferon (IFN) gama
Comparison of pre and post-dialysis of IFN gama
Measured: 3 months
Comparison of pre and post-dialysis necrosis factor (TNF) alpha
Comparison of pre and post-dialysis of TNF alpha
Measured: 3 months
Comparison of pre and post-dialysis of IL-4
Comparison of pre and post-dialysis of IL-4
Measured: 3 months
Comparison of pre and post-dialysis of Urea
Comparison of pre and post-dialysis of Urea
Measured: 3 months
Comparison of pre and post-dialysis of creatinine
Comparison of pre and post-dialysis of creatinine
Measured: 3 months
Comparison of pre and post-dialysis of beta2 microglobulin
Comparison of pre and post-dialysis of beta2 microglobulin
Measured: 3 months
Comparison of pre and post-dialysis of free light chain kappa
Comparison of pre and post-dialysis of free light chain kappa
Measured: 3 months
Comparison of pre and post-dialysis of free light chain lambda
Comparison of pre and post-dialysis of free light chain lambda
Measured: 3 months
Comparison of pre and post-dialysis of myoglobulin
Comparison of pre and post-dialysis of myoglobulin
Measured: 3 months
Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23
Comparison of pre and post-dialysis of FGF 23
Measured: 3 months
Comparison of pre and post-dialysis IL-18 levels
Comparison of pre and post-dialysis IL-18 levels
Measured: 3 months
Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels
Comparison of pre and post-dialysis MCP-1 levels
Measured: 3 months
Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels
Comparison of pre and post-dialysis NLRP3 levels
Measured: 3 months
Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)
Comparison of pre and post-dialysis RANTES
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuri Baris Hasbal, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Mustafa Sevinc, MD, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836508
- Sponsor's protocol ID
- 1909
- Status last verified
- Mar 2020
- First submitted
- 20 Jan 2019
- Last updated
- 19 Mar 2020
- 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
- ClinicalTrials.gov ID
- NCT03836508
- Acronym / sponsor ID
- 1909
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 11 Feb 2019 (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.
Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium cut-off | Active comparator | Device: Medium cut-off, Device: High-FluxMedium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers. |
| High-flux | Active comparator | Device: Medium cut-off, Device: High-FluxHigh-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who are older than 18 years and younger than 65 years
- patient with end-stage renal disease, hemodialysis more than 6 months
- patients under hemodialysis with high-flux dialyzer more than 3 months
- patients willing to participate after given fair and clear information about study
Key exclusion criteria (8 listed)
- patients living with Hepatitis B or C,
- patients with malignancy
- patients under immunosuppressive treatment
- patients with autoimmune diseases such as systemic lupus erythematosus, etc.
- patients with active infections
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 |
|---|---|---|
| Medium cut-offAll the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min | Device | High-flux, Medium cut-off |
| High-FluxAll the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min | Device | High-flux, Medium cut-off |
Primary outcome
Comparison of pre and post-dialysis of Interleukin (IL) 17-A
Time frame: 3 months
Comparison of pre and post-dialysis of IL-17A
15 secondary outcomes
Comparison of pre and post-dialysis of IL-10
Time frame: 3 months
Comparison of pre and post-dialysis of Interferon (IFN) gama
Time frame: 3 months
Comparison of pre and post-dialysis necrosis factor (TNF) alpha
Time frame: 3 months
Comparison of pre and post-dialysis of IL-4
Time frame: 3 months
Comparison of pre and post-dialysis of Urea
Time frame: 3 months
Comparison of pre and post-dialysis of creatinine
Time frame: 3 months
Comparison of pre and post-dialysis of beta2 microglobulin
Time frame: 3 months
Comparison of pre and post-dialysis of free light chain kappa
Time frame: 3 months
Comparison of pre and post-dialysis of free light chain lambda
Time frame: 3 months
Comparison of pre and post-dialysis of myoglobulin
Time frame: 3 months
Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23
Time frame: 3 months
Comparison of pre and post-dialysis IL-18 levels
Time frame: 3 months
Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels
Time frame: 3 months
Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels
Time frame: 3 months
Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)
Time frame: 3 months
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 19 Mar 2020.
- 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.
Mustafa Sevinc, MD principal investigator
Sisli Hamidiye Etfal 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?
A study testing Medium cut-off and High-Flux in people with Kidney Failure and Renal Insufficiency, Chronic, run by Sisli Hamidiye Etfal Training 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 4 inclusion and 8 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 19 Mar 2020. 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?
Comparison of pre and post-dialysis of Interleukin (IL) 17-A (time frame: 3 months). 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 19 Mar 2020.