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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Vincent Wu, doctor contact

886-937-223-278

dr.vincentwu@gmail.com

7 sites in 1 country

Taiwan7 sites, 7 recruiting
  • Kaohsiung Medical University Hospital

    Kaohsiung City

    SHANG-JHIH HUANG

    Not yet 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

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT05064904
Study groupRoleWhat they receive
never received RAAS blockers or multidiscipline consultation before AKI.Active comparatorThe 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 comparatorAll 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.

  1. Renal replacement therapy at any time after dialysis

    Patients will followed up at any time after dialysis.

    Measured: MAKE at 180 days

  2. survival

    Patients will followed up at any time after death.

    Measured: MAKE at 180 days

Secondary outcomes (1)
  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.

  1. First posted1 Oct 2021
  2. Study start15 Feb 2019
  3. Primary completion6 Jan 2024 (estimated)
  4. Study completion15 Feb 2024 (estimated)

Resources

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)
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

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.

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Multidiscipline Care for Acute Kidney Disease (AKD) | AzTrials