<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03305549</url>
  </required_header>
  <id_info>
    <org_study_id>F32DK115030</org_study_id>
    <nct_id>NCT03305549</nct_id>
  </id_info>
  <brief_title>Recovery After Dialysis-Requiring Acute Kidney Injury</brief_title>
  <acronym>RAD-AKI</acronym>
  <official_title>Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm&#xD;
      randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney&#xD;
      injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis&#xD;
      (control) to a &quot;conservative dialysis strategy&quot; in which hemodialysis is not continued unless&#xD;
      specific metabolic or clinical indications for RRT are present. The overall hypothesis is&#xD;
      that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks&#xD;
      evidence of renal recovery and may actually delay or preclude recovery. The primary objective&#xD;
      of this pilot study is to assess the safety and feasibility of the proposed intervention and&#xD;
      study design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a&#xD;
      delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT&#xD;
      was delayed unless specific metabolic or clinical indications for RRT were present - was safe&#xD;
      and averted the need for RRT in nearly half of the critically ill participants, in comparison&#xD;
      to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients&#xD;
      with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not&#xD;
      continued unless specific metabolic or clinical indications for RRT are present - will&#xD;
      shorten time to RRT-independence and improve the likelihood of renal recovery.&#xD;
&#xD;
      The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with&#xD;
      dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly&#xD;
      intermittent hemodialysis dialysis (control) to a &quot;conservative dialysis strategy.&quot; The&#xD;
      primary objective of this pilot study is to assess the safety and feasibility of the proposed&#xD;
      intervention and study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped because sufficient pilot data collected to proceed to next clinical trial.&#xD;
  </why_stopped>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">November 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a &quot;conservative dialysis strategy.&quot;</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Protocol adherence [feasibility measure]</measure>
    <time_frame>Through completion of active study participation (anticipated &lt;2 weeks for each participant)</time_frame>
    <description>Number of times a participant in the &quot;conservative dialysis&quot; arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the &quot;TIW dialysis&quot; arm is dialyzed off-schedule</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events in each arm [safety measure]</measure>
    <time_frame>Through completion of active study participation (anticipated &lt;2 weeks for each participant)</time_frame>
    <description>Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-reported symptoms</measure>
    <time_frame>Through completion of active study participation (anticipated &lt;2 weeks for each participant)</time_frame>
    <description>Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Through completion of active study participation (anticipated &lt;2 weeks for each participant)</time_frame>
    <description>Length of inpatient admission, starting after study enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery status at 30, 60, and 90 days after dialysis initiation</measure>
    <time_frame>From enrollment to 90 days after dialysis initiation for each patient</time_frame>
    <description>Assessment of recovery status via phone call or e-mail contact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screen-to-enroll ratio [feasibility measure]</measure>
    <time_frame>Through study completion (anticipated 2 years total)</time_frame>
    <description>Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>TIW Dialysis Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative Dialysis Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conservative dialysis strategy</intervention_name>
    <description>Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):&#xD;
Blood urea nitrogen &gt;112 mg/dL (40 mmol/L)&#xD;
Serum potassium concentration &gt;6 mmol/L&#xD;
Serum potassium concentration &gt;5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate)&#xD;
Arterial blood gas pH &lt;7.15 in a context of pure metabolic acidosis (PaCO2 &lt;35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate &lt;12 mmol/L&#xD;
Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate &gt;5 L/min to maintain SpO2 &gt;95% or requiring FiO2 &gt;50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy</description>
    <arm_group_label>Conservative Dialysis Strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TIW dialysis strategy</intervention_name>
    <description>Thrice-weekly acute intermittent hemodialysis schedule.</description>
    <arm_group_label>TIW Dialysis Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated&#xD;
             renal replacement therapy&#xD;
&#xD;
          -  If initiated on CRRT, patients will be eligible only if they have already tolerated 1&#xD;
             intermittent hemodialysis (IHD) session at the research site.&#xD;
&#xD;
          -  If transferred from an outside hospital, eligible patients must have tolerated 1 IHD&#xD;
             session at the research site prior to enrollment.&#xD;
&#xD;
          -  Not requiring vasopressor support&#xD;
&#xD;
          -  Not intubated and not having a supplemental oxygen requirement of &gt;5 L/min via nasal&#xD;
             cannula&#xD;
&#xD;
          -  Treating MDs (nephrology and primary team attendings) and patient (or legally&#xD;
             authorized representative) consent to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to&#xD;
             hospitalization&#xD;
&#xD;
          -  Baseline estimated glomerular filtration rate (eGFR) &lt;15 mL/min/1.73m2&#xD;
&#xD;
          -  Liver transplant unit patients&#xD;
&#xD;
          -  Patients who underwent kidney transplantation during index hospitalization&#xD;
&#xD;
          -  Cause of AKI-D is complete nephrectomy&#xD;
&#xD;
          -  Current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chi-yuan Hsu, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathleen Liu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Medical Center Moffitt-Long Hospital</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dialysis-requiring Acute Kidney Injury</keyword>
  <keyword>Renal Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03305549
org study id: F32DK115030
nct id: NCT03305549
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm
      randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney
      injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis
      (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless
      specific metabolic or clinical indications for RRT are present. The overall hypothesis is
      that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks
      evidence of renal recovery and may actually delay or preclude recovery. The primary objective
      of this pilot study is to assess the safety and feasibility of the proposed intervention and
      study design.
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a
      delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT
      was delayed unless specific metabolic or clinical indications for RRT were present - was safe
      and averted the need for RRT in nearly half of the critically ill participants, in comparison
      to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients
      with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not
      continued unless specific metabolic or clinical indications for RRT are present - will
      shorten time to RRT-independence and improve the likelihood of renal recovery.

      The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with
      dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly
      intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The
      primary objective of this pilot study is to assess the safety and feasibility of the proposed
      intervention and study design.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
primary purpose: Treatment
masking: None (Open Label)
measure: Protocol adherence [feasibility measure]
time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
description: Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
measure: Number of participants with adverse events in each arm [safety measure]
time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
description: Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
measure: Patient-reported symptoms
time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
description: Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
measure: Hospital length of stay
time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
description: Length of inpatient admission, starting after study enrollment
measure: Recovery status at 30, 60, and 90 days after dialysis initiation
time frame: From enrollment to 90 days after dialysis initiation for each patient
description: Assessment of recovery status via phone call or e-mail contact
measure: Screen-to-enroll ratio [feasibility measure]
time frame: Through study completion (anticipated 2 years total)
description: Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
arm group label: TIW Dialysis Strategy
arm group type: Active Comparator
description: Conventional thrice-weekly acute intermittent hemodialysis treatment schedule.
arm group label: Conservative Dialysis Strategy
arm group type: Experimental
description: Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present.
intervention type: Other
intervention name: Conservative dialysis strategy
description: Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):
Blood urea nitrogen >112 mg/dL (40 mmol/L)
Serum potassium concentration >6 mmol/L
Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate)
Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L
Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy
arm group label: Conservative Dialysis Strategy
intervention type: Other
intervention name: TIW dialysis strategy
description: Thrice-weekly acute intermittent hemodialysis schedule.
arm group label: TIW Dialysis Strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Chi-yuan Hsu, MD, MSc
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Kathleen Liu, MD, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
sharing ipd: No