Primary Outcome : Compare Percent CRP ReductionNCT06227104
Efficacy of Convection-based HDF Compare With Diffusion-based HD in Sepsis-associated AKI
A study testing Convection-based Hemodiafiltration in people with Primary Outcome : Compare Percent CRP Reduction and Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
Acute kidney injury (AKI) is a common complication among patient admitted in the hospital worldwide, with estimates of prevalence ranging from less than 1% to 66%.1, 2 In critically ill patients approximately 49% were acute kidney injury network (AKIN) stage 3 which required intensive care unit (ICU) admission, kidney… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Outcome : Compare Percent CRP Reduction, Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay
- What is being tested?
- Convection-based Hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2023to 1 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis-associated AKI requiring KRT
- Age >18 years old
Who cannot join
- Pregnancy
- Patients with end stage kidney disease who are currently receiving kidney replacement therapy (chronic hemodialysis, peritoneal dialysis, kidney transplantation)
- Patient who has refused to consent
- Patient who dead or aim to dead within 24 hours after randomization
- Patient who is receiving very high dose of vasopressor (norepinephrine > 1 mcg/kg/min)
- Patient who is receiving CRRT at first randomization
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
Chamanant Satjanon, MD, +66896968108, may.ninthnov@gmail.com
Adisorn Pathumarak, MD, +66896677980, adisorn.pat@mahidol.ac.th
About this study
Official title: Efficacy of Convection-based Hemodiafiltration Compare With Diffusion-based Hemodialysis in Sepsis-associated Acute Kidney Injury: A Randomized Controlled Trial
Acute kidney injury (AKI) is a common complication among patient admitted in the hospital worldwide, with estimates of prevalence ranging from less than 1% to 66%.1, 2 In critically ill patients approximately 49% were acute kidney injury network (AKIN) stage 3 which required intensive care unit (ICU) admission, kidney replacement therapy (KRT), and is associated with higher mortality rate.3 Sepsis-associated acute kidney injury (S-AKI) is a frequent complication in critically ill patient and is associated with high morbidity and mortality. S-AKI is defined as AKI in presence of sepsis without other significant contributing factors or simultaneous presence of both Sepsis-3 definition and Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI. 4, 5 Multicentre studies show that 30-60% of critically ill patient having AKI, and approximately 10-15% require KRT.6 Both Online-hemodiafiltration (OL-HDF) which is convection-based hemodiafiltration and conventional intermittent hemodialysis (IHD) which is diffusion-based hemodialysis are modalities of KRT that can be used to treat AKI in sepsis.7 Conventional intermittent hemodialysis (IHD) involves the removal of waste products and excess fluids from the blood by using a semipermeable membrane that acts as an artificial kidney. However, IHD has limitations in removing certain larger solutes, such as cytokines, which are involved in the inflammatory response associated with sepsis. In contrast, OL-HDF is a more advanced form of hemodialysis (HD) that combines convective clearance with diffusive clearance, resulting in more efficient removal of larger solutes.8 Several studies have suggested that OL-HDF may have advantages over conventional HD in the management of sepsis-associated AKI.9 Some studies found that OL-HDF was associated with improved patient survival and lower incidence of dialysis dependence compared to conventional IHD. Additionally, some studies have suggested that OL-HDF may have anti-inflammatory effects, which could be beneficial in sepsis.9-11 Some observational studies have shown that OL-HDF provide benefit over IHD including, a reduction in the length of ICU stay and a decrease in inflammatory surrogate markers. However, the effect of OL-HDF in improving survival has not yet been established. 1, 7, 9 Some studies have shown that sustained low-efficiency dialysis (SLED) may has advantage in hospital survival in over the continuous veno-venous hemofiltration (CVVH) modality.12 While there are several extracorporeal treatment modalities for AKI in critically ill patients but no randomized study has yet demonstrated a survival benefit over another.
A prospective and comparative study between IHD and OL-HDF groups showed no significant difference in mortality between the groups. However, a significant benefit in terms of a reduced length of ICU stays and vasopressor free day was found in the OL-HDF group.13 The past studies show that CRP and IL-6 levels increase in patients treated with IHD and remain stable in patients treated with OL-HDF, with a statistically significant difference. 14 In AKI patient, our aim is to remove small molecules such as uremic toxin or metabolic abnormalities. In chronic kidney disease, the benefit of high flux dialyser or OL-HDF to remove middle to large molecule such as ß2-microglobulin and others chronic inflammation molecules and cytokines through a combination of diffusion-based and convection-based techniques are well-known. These cytokines including C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), procalcitonin (PCT), which are commonly elevated in AKI patient, have been shown to be significantly reduced by using hemodiafiltration techniques. 9, 15 However, the benefits of removing middle molecule and inflammatory makers in the acute setting such as AKI in critically ill patient remain controversial.11, 16, 17 Therefore, this study aims to verify the benefit of convection-based treatment in reducing inflammatory molecule such as CRP over diffusion-based treatment in both critically-ill and standard AKI patients.
However, it is important to note that OL-HDF requires specialized equipment and may be more complex to administer compared to conventional IHD. Additionally, it is generally more expensive. Therefore, the choice of KRT modality in sepsis-associated AKI should be based on careful consideration of the individual patient's clinical status and available resources.7 It is important to note that every patient's condition is unique and requires individualized treatment, so the specific choice of KRT modality should be made in consultation with a healthcare professional.
Read the detailed description
Study design: Stratified randomized controlled trial, parallel group Population: Sepsis-associated AKI requiring KRT patient Hospital: Ramathibodi hospital and Chakri Naruebodindra Medical Institute (CNMI) Randomization: Stratified Randomization based on hemodynamics of the patient (envelope technique)
- In hemodynamic unstable group (allocation 1:1) Sustained low-efficiency diafiltration (SLED-f) vs. Sustained low-efficiency dialysis (SLED) SLED-f is representative of convection-based KRT in critically ill patient. Dialysis prescription: Nikkiso DBB-05 (Tokyo Japan) Hemodiafiltration machine, High-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum blood flow rate (BFR) 200-250 ml/min, minimum dialysate flow rate (DFR) 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min SLED is representative of diffusion-based KRT in critically ill patient which is currently a standard of dialysis care in hemodynamic unstable AKI patient.
Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisio 170L) dialyzer (Nipro, Japan), minimum BFR 150-250 ml/min, minimum DFR 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5 oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication
- In hemodynamic stable group (allocation 1:1) Online hemodiafiltration (OL HDF) vs. Intermittent hemodialysis (IHD) OL HDF is representative of convection-based KRT in hemodynamic stable AKI patient Dialysis prescription: Nikkiso DBB-05 (Tokyo, Japan) or Fresenius 5008 (Bad homburg, Germany) online-hemodialysis machine, high-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min IHD is representative of diffusion-based dialysis treatment which is currently a standard of dialysis care in hemodynamic stable AKI patient.
Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5 oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication
- Conditions
- Primary Outcome : Compare Percent CRP Reduction, Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay
- Being tested
- Convection-based Hemodiafiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convection-based HemodiafiltrationDevice
Convection-based Hemodiafiltration with pre substitution fluid
| Study group | Role | What they receive |
|---|---|---|
| Online hemodiafiltration (OL HDF) | Experimental | Prescription: Nikkiso DBB-05 or Fresenius 5008 machine, high-flux polysulfone dialyzer, BFR 200-300, DFR 500, duration 4 hrs Receives: Device: Convection-based Hemodiafiltration |
| Intermittent hemodialysis (IHD) | No intervention | Fresenius 4008 hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer, minimum BFR 200-300, DFR 500, duration 4 hrs |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent CRP reduction
compare percent change of CRP before HD vs after HD
Measured: before and after 4 hours of HD and at 48 hours or before second HD
Secondary outcomes (1)
30-day mortality rate, renal recovery rate, length of hospital stay
compare difference between group
Measured: at 30 days after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jun 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Outcome : Compare Percent CRP ReductionStudies 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
- Model description
- Patients with sepsis-associated AKI who need kidney replacement therapy in Ramathibodi Hospital will be divided into two arms. First convection base hemodiafiltration which basically removes solute by convection mode. Second is hemodialysis which the majority of clearance is the diffusion base method.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Arkom Nongnuch, Supawadee Suppadungsuk, Adisorn Pathumarak
- Responsible party
- Principal investigator, Chamanant Satjanon, Ramathibodi Hospital
- Investigators
- Chamanant Satjanon, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227104
- Sponsor's protocol ID
- 4724
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Convection-based Hemodiafiltration Compare With Diffusion-based Hemodialysis in Sepsis-associated Acute Kidney Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06227104
- Acronym / sponsor ID
- 4724
- Conditions
- Primary Outcome : Compare Percent CRP Reduction, Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Arkom Nongnuch, Supawadee Suppadungsuk, Adisorn Pathumarak
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 Jan 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.
Acute kidney injury (AKI) is a common complication among patient admitted in the hospital worldwide, with estimates of prevalence ranging from less than 1% to 66%.1, 2 In critically ill patients approximately 49% were acute kidney injury network (AKIN) stage 3 which required intensive care unit (ICU) admission, kidney replacement therapy (KRT), and is associated with higher mortality rate.3 Sepsis-associated acute kidney injury (S-AKI) is a frequent complication in critically ill patient and is associated with high morbidity and mortality. S-AKI is defined as AKI in presence of sepsis without other significant contributing factors or simultaneous presence of both Sepsis-3 definition and Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI. 4, 5 Multicentre studies show that 30-60% of critically ill patient having AKI, and approximately 10-15% require KRT.6 Both Online-hemodiafiltration (OL-HDF) which is convection-based hemodiafiltration and conventional intermittent hemodialysis (IHD) which is diffusion-based hemodialysis are modalities of KRT that can be used to treat AKI in sepsis.7 Conventional intermittent hemodialysis (IHD) involves the removal of waste products and excess fluids from the blood by using a semipermeable membrane that acts as an artificial kidney. However, IHD has limitations in removing certain larger solutes, such as cytokines, which are involved in the inflammatory response associated with sepsis. In contrast, OL-HDF is a more advanced form of hemodialysis (HD) that combines convective clearance with diffusive clearance, resulting in more efficient removal of larger solutes.8 Several studies have suggested that OL-HDF may have advantages over conventional HD in the management of sepsis-associated AKI.9 Some studies found that OL-HDF was associated with improved patient survival and lower incidence of dialysis dependence compared to conventional IHD. Additionally, some studies have suggested that OL-HDF may have anti-inflammatory effects, which could be beneficial in sepsis.9-11 Some observational studies have shown that OL-HDF provide benefit over IHD including, a reduction in the length of ICU stay and a decrease in inflammatory surrogate markers. However, the effect of OL-HDF in improving survival has not yet been established. 1, 7, 9 Some studies have shown that sustained low-efficiency dialysis (SLED) may has advantage in hospital survival in over the continuous veno-venous hemofiltration (CVVH) modality.12 While there are several extracorporeal treatment modalities for AKI in critically ill patients but no randomized study has yet demonstrated a survival benefit over another.
A prospective and comparative study between IHD and OL-HDF groups showed no significant difference in mortality between the groups. However, a significant benefit in terms of a reduced length of ICU stays and vasopressor free day was found in the OL-HDF group.13 The past studies show that CRP and IL-6 levels increase in patients treated with IHD and remain stable in patients treated with OL-HDF, with a statistically significant difference. 14 In AKI patient, our aim is to remove small molecules such as uremic toxin or metabolic abnormalities. In chronic kidney disease, the benefit of high flux dialyser or OL-HDF to remove middle to large molecule such as ß2-microglobulin and others chronic inflammation molecules and cytokines through a combination of diffusion-based and convection-based techniques are well-known. These cytokines including C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), procalcitonin (PCT), which are commonly elevated in AKI patient, have been shown to be significantly reduced by using hemodiafiltration techniques. 9, 15 However, the benefits of removing middle molecule and inflammatory makers in the acute setting such as AKI in critically ill patient remain controversial.11, 16, 17 Therefore, this study aims to verify the benefit of convection-based treatment in reducing inflammatory molecule such as CRP over diffusion-based treatment in both critically-ill and standard AKI patients.
However, it is important to note that OL-HDF requires specialized equipment and may be more complex to administer compared to conventional IHD. Additionally, it is generally more expensive. Therefore, the choice of KRT modality in sepsis-associated AKI should be based on careful consideration of the individual patient's clinical status and available resources.7 It is important to note that every patient's condition is unique and requires individualized treatment, so the specific choice of KRT modality should be made in consultation with a healthcare professional.
Detailed description
Study design: Stratified randomized controlled trial, parallel group Population: Sepsis-associated AKI requiring KRT patient Hospital: Ramathibodi hospital and Chakri Naruebodindra Medical Institute (CNMI) Randomization: Stratified Randomization based on hemodynamics of the patient (envelope technique)
- In hemodynamic unstable group (allocation 1:1) Sustained low-efficiency diafiltration (SLED-f) vs. Sustained low-efficiency dialysis (SLED) SLED-f is representative of convection-based KRT in critically ill patient. Dialysis prescription: Nikkiso DBB-05 (Tokyo Japan) Hemodiafiltration machine, High-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum blood flow rate (BFR) 200-250 ml/min, minimum dialysate flow rate (DFR) 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min SLED is representative of diffusion-based KRT in critically ill patient which is currently a standard of dialysis care in hemodynamic unstable AKI patient.
Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisio 170L) dialyzer (Nipro, Japan), minimum BFR 150-250 ml/min, minimum DFR 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5 oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication
- In hemodynamic stable group (allocation 1:1) Online hemodiafiltration (OL HDF) vs. Intermittent hemodialysis (IHD) OL HDF is representative of convection-based KRT in hemodynamic stable AKI patient Dialysis prescription: Nikkiso DBB-05 (Tokyo, Japan) or Fresenius 5008 (Bad homburg, Germany) online-hemodialysis machine, high-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min IHD is representative of diffusion-based dialysis treatment which is currently a standard of dialysis care in hemodynamic stable AKI patient.
Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5 oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with sepsis-associated AKI who need kidney replacement therapy in Ramathibodi Hospital will be divided into two arms. First convection base hemodiafiltration which basically removes solute by convection mode. Second is hemodialysis which the majority of clearance is the diffusion base method.
| Arm | Type | Receives |
|---|---|---|
| Online hemodiafiltration (OL HDF) | Experimental | Device: Convection-based HemodiafiltrationPrescription: Nikkiso DBB-05 or Fresenius 5008 machine, high-flux polysulfone dialyzer, BFR 200-300, DFR 500, duration 4 hrs |
| Intermittent hemodialysis (IHD) | No intervention | –Fresenius 4008 hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer, minimum BFR 200-300, DFR 500, duration 4 hrs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sepsis-associated AKI requiring KRT
- Age >18 years old
Key exclusion criteria (6 listed)
- Pregnancy
- Patients with end stage kidney disease who are currently receiving kidney replacement therapy (chronic hemodialysis, peritoneal dialysis, kidney transplantation)
- Patient who has refused to consent
- Patient who dead or aim to dead within 24 hours after randomization
- Patient who is receiving very high dose of vasopressor (norepinephrine > 1 mcg/kg/min)
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 |
|---|---|---|
| Convection-based HemodiafiltrationConvection-based Hemodiafiltration with pre substitution fluid | Device | Online hemodiafiltration (OL HDF) |
Primary outcome
percent CRP reduction
Time frame: before and after 4 hours of HD and at 48 hours or before second HD
compare percent change of CRP before HD vs after HD
1 secondary outcome
30-day mortality rate, renal recovery rate, length of hospital stay
Time frame: at 30 days after allocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Undecided
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.
Chamanant Satjanon, MD principal investigator
Ramathibodi 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 Convection-based Hemodiafiltration in people with Primary Outcome : Compare Percent CRP Reduction and Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay, run by Ramathibodi Hospital at 1 site in Thailand.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jan 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chamanant Satjanon, MD (+66896968108, may.ninthnov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent CRP reduction (time frame: before and after 4 hours of HD and at 48 hours or before second HD). 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 26 Jan 2024.