Acute Kidney InjuryAKDNCT05064904
Multidiscipline Care for Acute Kidney Disease (AKD)
A study testing never received RAAS blockers or received RAAS blockers before AKI. in people with Acute Kidney Injury, run by National Taiwan University Hospital at 7 sites in Taiwan.
Trial summary
The Taiwan Consortium of Acute Kidney Injury and Renal Diseases (TCTC) is leading a clinical trial group in Asia-Pacific to reduce the morbidity and mortality associated with acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- never received RAAS blockers or received RAAS blockers before AKI.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesTaiwan
- Study dates
- 15 Feb 2019to 15 Feb 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years old on the day of index discharge
- AKI develops during admission, as defined with KDIGO-AKI Guideline, namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5 times baseline and ever receives dialysis during this index hospitalization.
- Patients who has KDIGO-AKI stage 2, 3 or who could wean from dialysis requiring AKI-D in the index hospitalization.
Who cannot join
- Baseline estimated glomerular filtration rates (eGFR) less than 5ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation after index discharge.
- Patients receive further re-dialysis within 90 days after index hospital discharge, who are withdrawal for AKI-D. (sensors)
- Previous gastrointestinal operations.
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
- Solid organ or hematological transplantation donors.
Show all 9Show fewer
- Evidence of obstructive acute kidney injury.
- Systolic blood pressure < 110mmHg.
- Pregnant women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Not yet recruiting
Kaohsiung Medical University Hospital
Kaohsiung City
SHANG-JHIH HUANG
- Recruiting
Keelung CGMH
Keelung
Heng-Chih Pan
Heng-Chih Pan
- Recruiting
China Medical University Hospital
Taichung
Ya-Fei Yang
Ya-Fei Yang
- Recruiting
Taichung Veterans General Hospital
Taichung
Ming-Ju Wu
Ming-Ju Wu
- Recruiting
National Taiwan University Hospital
Taipei
Vincent Wu, doctor, 886-937223278, dr.vincentwu@gmail.com
- Recruiting
Taipei Veterans General Hospital
Taipei
Der-Cherng Tarng
Der-Cherng Tarng
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
CHIH-HSIANG CHANG
CHIH-HSIANG CHANG
About this study
Official title: Multidiscipline Care for Acute Kidney Injury to Chronic Kidney Disease Transition (Acute Kidney Disease) - a Randomized Controlled Study
The Taiwan Consortium of Acute Kidney Injury and Renal Diseases (TCTC) is leading a clinical trial group in Asia-Pacific to reduce the morbidity and mortality associated with acute kidney injury (AKI). The trial is a double two-by-two factorial design that will collect demographic and clinical information of AKI stage 2, 3, or weaning from dialysis-requiring AKI patients (AKI-D) to explore the epidemiology, risk factors and prognosis of AKI in Taiwan. Patients will be randomized either to add Angiotensin-Converting Enzyme Inhibitors (ACE-I)/Angiotensin II Receptor Blocker (ARB) to slow kidney function progression, or to receive multidisciplinary care. Patients will be followed up for a minimum of 6 months to evaluate kidney function, the predictability of developing chronic kidney disease, end stage renal disease, major cardiovascular events, and mortality.
Read the detailed description
In the past decade, acute kidney injury (AKI) has emerged as a syndrome of increasing prevalence. Since 2005, hospital-diagnosed cases of AKI have outnumbered those of chronic kidney disease (CKD), and this trend has continued to climb. Patients diagnosed with AKI are at risk for a variety of adverse outcomes, including premature death, morbidity, prolonged hospitalization, and increased medical costs. Potential contributing factors to the development of AKI include pre-existing kidney damage, hemodynamic instability, and the complexity of concurrent medications. As modern medical diagnostic and treatment tools have advanced, the incidence and prevalence of AKI have been steadily rising.
The KDIGO Guideline for AKI recommended that we should diagnose AKI if a given patient has a 6 hour urine amount less than 0.5ml/kg/hr or a serum creatinine elevates more than 0.3mg/dL or 1.5 times greater than baselines. Epidemiology data on hospitalized patients indeed disclosed high risk for adverse events using this classification system and its analogues. However, besides diagnosis, we do not have a useful tool to treat or to help improve patient outcomes Acute kidney injury (AKI) is a common complication that affects nearly 5% of hospitalized patients and 40%-70% of patients in the intensive care unit. AKI requiring dialysis (AKI-D), the most severe type of AKI, is associated with the highest proportion of morbidity and mortality. AKI is associated with a risk of end-stage renal disease (ESRD) that is 13 times as high as the risk among patients without AKI, and the risk of ESRD is 40 times as high if the patients have both AKI and pre-existing chronic kidney disease (CKD). Since AKI is recognized as a risk factor for the development of ESRD, it is crucial to have appropriate protection strategies for the avoidance of further target organ damage and associated mortality in the critical phases of the acute kidney disease (AKD). Patients with Acute Kidney Injury (AKI) requiring dialysis (AKI-D) are associated with the highest proportion of morbidity and mortality. AKI is associated with a thirteen-fold higher risk of end-stage renal disease (ESRD) compared to those without AKI, and a forty-fold higher risk if the patient has both AKI and pre-existing chronic kidney disease (CKD). Given the potential for AKI to lead to ESRD, it is essential to develop strategies to protect the target organs from further damage and associated mortality during the acute phase of AKD. Guyton proposed that the kidneys have a crucial role in determining the chronic level of blood pressure (BP), and studies have validated this hypothesis. Furthermore, hospitalization-associated AKI has been identified as an independent risk factor for the development of elevated BP. Elevated BP is a leading risk factor for global health and cardiovascular disease, making it a key element in the pharmacologic treatment and long-term protection of AKD patients. A retrospective analysis of the ICU database, which included 1551 ICU survivors, 611 of which had AKI during their stay, demonstrated a reduced 1-year mortality in those who had AKI and had been prescribed ACEIs/ARBs.
To address the gap between acute kidney injury (AKI) and chronic kidney disease (CKD), the Kidney Disease: Improving Global Outcomes (KDIGO) AKI Workgroup has proposed the concept of acute kidney disease (AKD). AKD is defined as a glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 or evidence of structural kidney damage that has been present for less than 3 months. This concept provides an integrated bridge between AKI and CKD and also emphasizes the concept of partial renal recovery. It may help to raise awareness and create the necessary clinical mechanisms to follow up AKI survivors for the potential progression to CKD, which has been recently highlighted as a missed opportunity for adequate transitions of care. Furthermore, a panel of gut microbiota and biomarkers will be determined.
- Conditions
- Acute Kidney Injury
- Being tested
- never received RAAS blockers or received RAAS blockers before AKI.
- Keywords
- Chronic kidney disease, Acute kidney disease
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
never received RAAS blockers or received RAAS blockers before AKI.Drug
Also called Multidiscipline consultation
Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D).
All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, <130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge.
| Study group | Role | What they receive |
|---|---|---|
| never received RAAS blockers or multidiscipline consultation before AKI. | Active comparator | The enrollees assigned to the control group should not receive RAAS blockers or AKD consultation at least in 180 days after index discharge. In addition, these multidiscipline consultation and administration of RAAS blockers are continuing, and results regarding them remain masked. All patients provided written informed consent. Receives: Drug: never received RAAS blockers or received RAAS blockers before AKI. |
| had received RAAS blockers and multidiscipline consultation before AKI. | Active comparator | All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, <130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge.
Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D). Receives: Drug: never received RAAS blockers or received RAAS blockers before AKI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal replacement therapy at any time after dialysis
Patients will followed up at any time after dialysis.
Measured: MAKE at 180 days
survival
Patients will followed up at any time after death.
Measured: MAKE at 180 days
Secondary outcomes (1)
Rehospitalization
Rehospitalization from myocardial infarction, heart failure, arrhythmia, invasive cardiovascular interventions, cardiovascular causes after noncardiovascular surgery, stroke.
Measured: MAKE at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Feb 2019
- Primary completion6 Jan 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The randomization procedure was developed at the WHI Clinical Coordinating Center and implemented locally through a distributed study database, using a randomized permuted block algorithm, stratified by clinical center site, diabetics mellitus and age group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Vincent Wu, doctor, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064904
- Sponsor's protocol ID
- 201811079MINC
- Other IDs
- 201900796A3C502
- Acronym
- AKD
- Status last verified
- Mar 2023
- First submitted
- 11 Jun 2021
- Last updated
- 8 Mar 2023
- 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidiscipline Care for Acute Kidney Injury to Chronic Kidney Disease Transition (Acute Kidney Disease) - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05064904
- Acronym / sponsor ID
- AKD / 201811079MINC
- Conditions
- Acute Kidney Injury
- Keywords
- Chronic kidney disease, Acute kidney disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 6 Jan 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 1 Oct 2021 (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 Taiwan Consortium of Acute Kidney Injury and Renal Diseases (TCTC) is leading a clinical trial group in Asia-Pacific to reduce the morbidity and mortality associated with acute kidney injury (AKI). The trial is a double two-by-two factorial design that will collect demographic and clinical information of AKI stage 2, 3, or weaning from dialysis-requiring AKI patients (AKI-D) to explore the epidemiology, risk factors and prognosis of AKI in Taiwan. Patients will be randomized either to add Angiotensin-Converting Enzyme Inhibitors (ACE-I)/Angiotensin II Receptor Blocker (ARB) to slow kidney function progression, or to receive multidisciplinary care. Patients will be followed up for a minimum of 6 months to evaluate kidney function, the predictability of developing chronic kidney disease, end stage renal disease, major cardiovascular events, and mortality.
Detailed description
In the past decade, acute kidney injury (AKI) has emerged as a syndrome of increasing prevalence. Since 2005, hospital-diagnosed cases of AKI have outnumbered those of chronic kidney disease (CKD), and this trend has continued to climb. Patients diagnosed with AKI are at risk for a variety of adverse outcomes, including premature death, morbidity, prolonged hospitalization, and increased medical costs. Potential contributing factors to the development of AKI include pre-existing kidney damage, hemodynamic instability, and the complexity of concurrent medications. As modern medical diagnostic and treatment tools have advanced, the incidence and prevalence of AKI have been steadily rising.
The KDIGO Guideline for AKI recommended that we should diagnose AKI if a given patient has a 6 hour urine amount less than 0.5ml/kg/hr or a serum creatinine elevates more than 0.3mg/dL or 1.5 times greater than baselines. Epidemiology data on hospitalized patients indeed disclosed high risk for adverse events using this classification system and its analogues. However, besides diagnosis, we do not have a useful tool to treat or to help improve patient outcomes Acute kidney injury (AKI) is a common complication that affects nearly 5% of hospitalized patients and 40%-70% of patients in the intensive care unit. AKI requiring dialysis (AKI-D), the most severe type of AKI, is associated with the highest proportion of morbidity and mortality. AKI is associated with a risk of end-stage renal disease (ESRD) that is 13 times as high as the risk among patients without AKI, and the risk of ESRD is 40 times as high if the patients have both AKI and pre-existing chronic kidney disease (CKD). Since AKI is recognized as a risk factor for the development of ESRD, it is crucial to have appropriate protection strategies for the avoidance of further target organ damage and associated mortality in the critical phases of the acute kidney disease (AKD). Patients with Acute Kidney Injury (AKI) requiring dialysis (AKI-D) are associated with the highest proportion of morbidity and mortality. AKI is associated with a thirteen-fold higher risk of end-stage renal disease (ESRD) compared to those without AKI, and a forty-fold higher risk if the patient has both AKI and pre-existing chronic kidney disease (CKD). Given the potential for AKI to lead to ESRD, it is essential to develop strategies to protect the target organs from further damage and associated mortality during the acute phase of AKD. Guyton proposed that the kidneys have a crucial role in determining the chronic level of blood pressure (BP), and studies have validated this hypothesis. Furthermore, hospitalization-associated AKI has been identified as an independent risk factor for the development of elevated BP. Elevated BP is a leading risk factor for global health and cardiovascular disease, making it a key element in the pharmacologic treatment and long-term protection of AKD patients. A retrospective analysis of the ICU database, which included 1551 ICU survivors, 611 of which had AKI during their stay, demonstrated a reduced 1-year mortality in those who had AKI and had been prescribed ACEIs/ARBs.
To address the gap between acute kidney injury (AKI) and chronic kidney disease (CKD), the Kidney Disease: Improving Global Outcomes (KDIGO) AKI Workgroup has proposed the concept of acute kidney disease (AKD). AKD is defined as a glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 or evidence of structural kidney damage that has been present for less than 3 months. This concept provides an integrated bridge between AKI and CKD and also emphasizes the concept of partial renal recovery. It may help to raise awareness and create the necessary clinical mechanisms to follow up AKI survivors for the potential progression to CKD, which has been recently highlighted as a missed opportunity for adequate transitions of care. Furthermore, a panel of gut microbiota and biomarkers will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The randomization procedure was developed at the WHI Clinical Coordinating Center and implemented locally through a distributed study database, using a randomized permuted block algorithm, stratified by clinical center site, diabetics mellitus and age group.
| Arm | Type | Receives |
|---|---|---|
| never received RAAS blockers or multidiscipline consultation before AKI. | Active comparator | Drug: never received RAAS blockers or received RAAS blockers before AKI.The enrollees assigned to the control group should not receive RAAS blockers or AKD consultation at least in 180 days after index discharge. In addition, these multidiscipline consultation and administration of RAAS blockers are continuing, and results regarding them remain masked. All patients provided written informed consent. |
| had received RAAS blockers and multidiscipline consultation before AKI. | Active comparator | Drug: never received RAAS blockers or received RAAS blockers before AKI.All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, <130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge. Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 20 years old on the day of index discharge
- AKI develops during admission, as defined with KDIGO-AKI Guideline, namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5 times baseline and ever receives dialysis during this index hospitalization.
- Patients who has KDIGO-AKI stage 2, 3 or who could wean from dialysis requiring AKI-D in the index hospitalization.
Key exclusion criteria (9 listed)
- Baseline estimated glomerular filtration rates (eGFR) less than 5ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation after index discharge.
- Patients receive further re-dialysis within 90 days after index hospital discharge, who are withdrawal for AKI-D. (sensors)
- Previous gastrointestinal operations.
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
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 |
|---|---|---|
| never received RAAS blockers or received RAAS blockers before AKI.Also: Multidiscipline consultationEnrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D). All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, <130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge. | Drug | had received RAAS blockers and multidiscipline consultation before AKI., never received RAAS blockers or multidiscipline consultation before AKI. |
Primary outcome
Renal replacement therapy at any time after dialysis
Time frame: MAKE at 180 days
Patients will followed up at any time after dialysis.
survival
Time frame: MAKE at 180 days
Patients will followed up at any time after death.
1 secondary outcome
Rehospitalization
Time frame: MAKE at 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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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.
Vincent Wu, doctor principal investigator
NTUH
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing never received RAAS blockers or received RAAS blockers before AKI. in people with Acute Kidney Injury, run by National Taiwan University Hospital at 7 sites in Taiwan.
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 9 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. 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 Vincent Wu, doctor (886-937-223-278, dr.vincentwu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal replacement therapy at any time after dialysis (time frame: MAKE at 180 days). 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 8 Mar 2023.