ACEi ARB Withdrawal in CKD Patients

Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Disease; Blood Pressure; Angiotensin-converting Enzyme Inhibitor; Angiotensin Receptor Blockers
• Intervention / Treatment: Other: Continuation of ACEi and/or ARBs

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Divya Seth, BA; Phone Number: 415-514-0989; Email: divya.seth@ucsf.edu
• Study Contact Backup: Name: Elaine Ku, MD; Phone Number: 415-353-2507; Email: Elaine.Ku@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Divya Seth, BA; Phone Number: 415-917-3233; Email: divya.seth@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of enrollment and dropout in trial	measure of acceptability of continuing ACEi/ARBs among providers and patients	Months 1-12
Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)	safety measure	Months 1-12
Number of all cause emergency room visits	safety measure	Months 1-12
Number of all-cause hospitalizations	safety measure	Months 1-12
Number of falls and syncope reported by patients and/or discharge summaries	safety measure	Months 1-12
Number of patients who receive chronic dialysis or kidney transplant	Marks the onset of end-stage renal disease	Months 1-12

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Elaine Ku, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 18-25554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No