AKI - Acute Kidney InjuryNCT06440759
To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT
A study testing oXiris filter and M100 filter in people with AKI - Acute Kidney Injury and Pneumonia, run by Mohd Zulfakar Mazlan, MBBS at 1 site in Malaysia.
Trial summary
The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury, Pneumonia
- What is being tested?
- oXiris filter and M100 filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 May 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- All adult patients aged>18 years old
- Diagnosis of septic shock
- Diagnosis of KDIGO stage 3 acute renal failure
Who cannot join
- Moribund patient or patient that is expected to die within 72 hours
- Pregnancy
- patient with a bleeding tendency or known allergy to heparin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia (HUSM)
Kubang Kerian, Kelantan, 16150
Mohd Zulfakar Mazlan, MBBS, +6097673000 ext. 6104, zulfakar@usm.my
About this study
Official title: Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)
The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI.
Read the detailed description
The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group
Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis.
The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry.
- Conditions
- AKI - Acute Kidney Injury, Pneumonia
- Being tested
- oXiris filter, M100 filter
- Medical subject headings
- Acute Kidney Injury, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris filterDevice
Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris.
The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.
M100 filterDevice
Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.
| Study group | Role | What they receive |
|---|---|---|
| oXiris filter | Experimental | Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris.
The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.
The 28-day mortality will be recorded following treatment. Receives: Device: oXiris filter |
| M100 filter | Active comparator | Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.
The 28-day mortality will be recorded following treatment. Receives: Device: M100 filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6
To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline IL6 will be measured immediately before CRRT and post-CRRT
Measured: 24 hours
To compare the 28-days mortality of using oxiris filter during CRRT
To measure the 28-day mortality rate when using oxiris and M100 filter for CRRT. The 28-day mortality rate is calculated based on the number of deaths occurring within 28 days from a defined starting point, the start of CRRT.
Measured: 28 days
Secondary outcomes (5)
To compare the risk infection of by using oxiris during CRRT
To measure the risk of infection rate when using oxiris filter for CRRT. An infection is defined as an infection of the CRRT catheter such as CRBSI.
Measured: 28 days
To compare the risk bleeding of using oxiris during CRRT
To measure the risk of bleeding rate when using oxiris filter for CRRT. Bleeding is defined as any bleeding noted such as gastrointestinal, urinary bleeding or respiratory tract bleeding.
Measured: 28 days
To compare the risk of ventilator-free days of using oxiris during CRRT
To measure the risk of ventilator-free day rate when using oxiris filter for CRRT. It is defined as the number of days within a specific period (usually 28 days) during which a patient is both alive and free from mechanical ventilation. For example, if a patient is on mechanical ventilation for 10 days and survives the entire 28-day period, they would have 18 ventilator-free days (28 - 10 = 18). If a patient dies at any point within the 28 days, their VFDs would be zero.
Measured: 28 days
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT
To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline PCT will be measured immediately before CRRT and post-CRRT
Measured: 24 hours
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP
To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline CRP will be measured immediately before CRRT and Post CRRT
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 May 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohd Zulfakar Mazlan, MBBS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440759
- Sponsor's protocol ID
- USM/JEPeM/KK/23090718
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)
- ClinicalTrials.gov ID
- NCT06440759
- Acronym / sponsor ID
- USM/JEPeM/KK/23090718
- Conditions
- AKI - Acute Kidney Injury, Pneumonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohd Zulfakar Mazlan, MBBSUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI.
Detailed description
The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group
Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis.
The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oXiris filter | Experimental | Device: oXiris filterContinuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. The 28-day mortality will be recorded following treatment. |
| M100 filter | Active comparator | Device: M100 filterContinuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. The 28-day mortality will be recorded following treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients aged>18 years old
- Diagnosis of septic shock
- Diagnosis of KDIGO stage 3 acute renal failure
Key exclusion criteria (3 listed)
- Moribund patient or patient that is expected to die within 72 hours
- Pregnancy
- patient with a bleeding tendency or known allergy to heparin
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 |
|---|---|---|
| oXiris filterContinuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. | Device | oXiris filter |
| M100 filterContinuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared. | Device | M100 filter |
Primary outcome
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6
Time frame: 24 hours
To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline IL6 will be measured immediately before CRRT and post-CRRT
To compare the 28-days mortality of using oxiris filter during CRRT
Time frame: 28 days
To measure the 28-day mortality rate when using oxiris and M100 filter for CRRT. The 28-day mortality rate is calculated based on the number of deaths occurring within 28 days from a defined starting point, the start of CRRT.
5 secondary outcomes
To compare the risk infection of by using oxiris during CRRT
Time frame: 28 days
To compare the risk bleeding of using oxiris during CRRT
Time frame: 28 days
To compare the risk of ventilator-free days of using oxiris during CRRT
Time frame: 28 days
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT
Time frame: 24 hours
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oXiris filter and M100 filter in people with AKI - Acute Kidney Injury and Pneumonia, run by Mohd Zulfakar Mazlan, MBBS at 1 site in Malaysia.
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 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Azidah Mat Zaid, MBBS (0199870715, marinazaid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6 (time frame: 24 hours). The study lists 2 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 2 Oct 2025.