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出境医 / 临床实验 / ACEi ARB Withdrawal in CKD Patients

ACEi ARB Withdrawal in CKD Patients

Study Description
Brief Summary:
The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Blood Pressure Angiotensin-converting Enzyme Inhibitor Angiotensin Receptor Blockers Other: Continuation of ACEi and/or ARBs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: ACEi/ARB continuation
Intervention group will continue or start to take ACEi and/or ARBs
 Other: Continuation of ACEi and/or ARBs
Patients will continue or start taking ACEi and/or ARBs
No Intervention: ACEi/ARB withdrawal
The control group will discontinue ACEi and/or ARBs which may be substituted with other anti-hypertensive agents (if already taking ACEi/ARB) or continue to not take ACEi/ARBs
Outcome Measures
Primary Outcome Measures :
  1. Rate of enrollment and dropout in trial [ Time Frame: Months 1-12 ]
    measure of acceptability of continuing ACEi/ARBs among providers and patients

  2. Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L) [ Time Frame: Months 1-12 ]
    safety measure

  3. Number of all cause emergency room visits [ Time Frame: Months 1-12 ]
    safety measure

  4. Number of all-cause hospitalizations [ Time Frame: Months 1-12 ]
    safety measure

  5. Number of falls and syncope reported by patients and/or discharge summaries [ Time Frame: Months 1-12 ]
    safety measure

  6. Number of patients who receive chronic dialysis or kidney transplant [ Time Frame: Months 1-12 ]
    Marks the onset of end-stage renal disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults ≥18 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have at least two eGFR in the last three months that are < 25 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR < 25 mL/min/1.73m2 in the past six months
  • receiving at least one antihypertensive medication at the time of the screening visit.

Exclusion Criteria:

The investigators will exclude those who:

  • are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
  • are marginally housed, due to concerns regarding routine follow-up
  • are actively participating in a different interventional trial that may affect blood pressure
  • are unwilling to consent to participate
  • institutionalized individuals or prisoners
  • are actively abusing illicit drugs or alcohol
  • have a history of poor or doubtful compliance (e.g., frequently missed appointments)
  • have cognitive impairment prohibiting participation in the study
  • on dialysis at time of recruitment
Contacts and Locations

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Elaine Ku, MD University of California, San Francisco
Principal Investigator: Raymond Hsu, MD University of California, San Francisco
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE September 7, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Rate of enrollment and dropout in trial [ Time Frame: Months 1-12 ]
    measure of acceptability of continuing ACEi/ARBs among providers and patients
  • Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L) [ Time Frame: Months 1-12 ]
    safety measure
  • Number of all cause emergency room visits [ Time Frame: Months 1-12 ]
    safety measure
  • Number of all-cause hospitalizations [ Time Frame: Months 1-12 ]
    safety measure
  • Number of falls and syncope reported by patients and/or discharge summaries [ Time Frame: Months 1-12 ]
    safety measure
  • Number of patients who receive chronic dialysis or kidney transplant [ Time Frame: Months 1-12 ]
    Marks the onset of end-stage renal disease
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Enrollment and dropout rates [ Time Frame: Months 1-12 ]
    measure of acceptability of continuing ACEi/ARBs among providers and patients
  • Onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L) [ Time Frame: Months 1-12 ]
    safety measure
  • Number of emergency room visits [ Time Frame: Months 1-12 ]
    safety measure, for all causes
  • All-cause hospitalization rates [ Time Frame: Months 1-12 ]
    safety measure
  • Number of falls and syncope reported by patients and/or discharge summaries [ Time Frame: Months 1-12 ]
    safety measure
  • Receipt of chronic dialysis or kidney transplant [ Time Frame: Months 1-12 ]
    Marks the onset of end-stage renal disease
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACEi ARB Withdrawal in CKD Patients
Official Title  ICMJE Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease
Brief Summary The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Blood Pressure
  • Angiotensin-converting Enzyme Inhibitor
  • Angiotensin Receptor Blockers
Intervention  ICMJE Other: Continuation of ACEi and/or ARBs
Patients will continue or start taking ACEi and/or ARBs
Study Arms  ICMJE
  • Experimental: ACEi/ARB continuation
    Intervention group will continue or start to take ACEi and/or ARBs
    Intervention: Other: Continuation of ACEi and/or ARBs
  • No Intervention: ACEi/ARB withdrawal
    The control group will discontinue ACEi and/or ARBs which may be substituted with other anti-hypertensive agents (if already taking ACEi/ARB) or continue to not take ACEi/ARBs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults ≥18 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have at least two eGFR in the last three months that are < 25 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR < 25 mL/min/1.73m2 in the past six months
  • receiving at least one antihypertensive medication at the time of the screening visit.

Exclusion Criteria:

The investigators will exclude those who:

  • are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
  • are marginally housed, due to concerns regarding routine follow-up
  • are actively participating in a different interventional trial that may affect blood pressure
  • are unwilling to consent to participate
  • institutionalized individuals or prisoners
  • are actively abusing illicit drugs or alcohol
  • have a history of poor or doubtful compliance (e.g., frequently missed appointments)
  • have cognitive impairment prohibiting participation in the study
  • on dialysis at time of recruitment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957161
Other Study ID Numbers  ICMJE 18-25554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elaine Ku, MD University of California, San Francisco
Principal Investigator: Raymond Hsu, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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