Back to resultsACEi ARB Withdrawal in CKD Patients
Primary Purpose
Chronic Kidney Disease, Blood Pressure, Angiotensin-converting Enzyme Inhibitor
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuation of ACEi and/or ARBs
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility 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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ACEi/ARB continuation
ACEi/ARB withdrawal
Arm Description
Intervention group will continue or start to take ACEi and/or ARBs
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
Outcomes
Primary Outcome Measures
Rate of enrollment and dropout in trial
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)
safety measure
Number of all cause emergency room visits
safety measure
Number of all-cause hospitalizations
safety measure
Number of falls and syncope reported by patients and/or discharge summaries
safety measure
Number of patients who receive chronic dialysis or kidney transplant
Marks the onset of end-stage renal disease
Secondary Outcome Measures
Full Information
NCT ID
NCT03957161
First Posted
May 15, 2019
Last Updated
October 31, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03957161
Brief Title
ACEi ARB Withdrawal in CKD Patients
Official Title
Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 7, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Blood Pressure, Angiotensin-converting Enzyme Inhibitor, Angiotensin Receptor Blockers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACEi/ARB continuation
Arm Type
Experimental
Arm Description
Intervention group will continue or start to take ACEi and/or ARBs
Arm Title
ACEi/ARB withdrawal
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Continuation of ACEi and/or ARBs
Intervention Description
Patients will continue or start taking ACEi and/or ARBs
Primary Outcome Measure Information:
Title
Rate of enrollment and dropout in trial
Description
measure of acceptability of continuing ACEi/ARBs among providers and patients
Time Frame
Months 1-12
Title
Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)
Description
safety measure
Time Frame
Months 1-12
Title
Number of all cause emergency room visits
Description
safety measure
Time Frame
Months 1-12
Title
Number of all-cause hospitalizations
Description
safety measure
Time Frame
Months 1-12
Title
Number of falls and syncope reported by patients and/or discharge summaries
Description
safety measure
Time Frame
Months 1-12
Title
Number of patients who receive chronic dialysis or kidney transplant
Description
Marks the onset of end-stage renal disease
Time Frame
Months 1-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Ku, MD
Phone
415-353-2507
Email
Elaine.Ku@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Divya Seth, BA
Phone
415-514-0989
Email
divya.seth@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Divya Seth, BA
Phone
415-917-3233
Email
divya.seth@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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ACEi ARB Withdrawal in CKD Patients
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