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ACEi ARB Withdrawal in CKD Patients

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ClinicalTrials.gov Identifier: NCT03957161
Recruitment Status : Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

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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 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957161


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
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03957161    
Other Study ID Numbers: 18-25554
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency