Clinical trial NCT03957161: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Disease
Blood Pressure
Angiotensin-converting Enzyme Inhibitor
Angiotensin Receptor Blockers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of enrollment and dropout in trial
timeFrame: Months 1-12
measure: Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)
timeFrame: Months 1-12
measure: Number of all cause emergency room visits
timeFrame: Months 1-12
measure: Number of all-cause hospitalizations
timeFrame: Months 1-12
measure: Number of falls and syncope reported by patients and/or discharge summaries
timeFrame: Months 1-12
measure: Number of patients who receive chronic dialysis or kidney transplant
timeFrame: Months 1-12
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Ku, MD
role: PRINCIPAL_INVESTIGATOR
References: